Abaloparatide: what the trials show, status and safety
Summary
Abaloparatide is a laboratory-made, slightly altered copy of a hormone fragment that switches on the body's bone-building cells. In the main trial, new spine fractures seen on X-ray affected 0.6 per cent of women on abaloparatide against 4.2 per cent on placebo over 18 months. The evidence for other fractures is weaker: the result away from the spine was borderline and did not hold up in the European reanalysis, and a benefit for the hip has never been shown. It is a prescription medicine in six major markets and carries a bone-cancer warning based on rat studies.
Key findings at a glance
- Spine fractures are the main result. In the 18-month ACTIVE trial, a new spine fracture on X-ray affected 0.6 per cent on abaloparatide and 4.2 per cent on placebo [1], [2], [3].
- The result for other fractures is fragile. Counting all centres, fractures away from the spine affected 2.2 against 4.0 per cent, a hazard ratio of 0.57 whose upper limit sat exactly at 1.00. Without two centres that broke trial rules, Europe found no significant difference [4], [5].
- Europe refused it once. The first application was rejected in January 2019, mainly over those fractures away from the spine. A second one, backed by real-world data, was approved in December 2022 [6], [7].
- There is no evidence for the hip. ACTIVE recorded two hip fractures in total, both on placebo, and the American regulator called the size of any hip benefit unknown [4].
- Against teriparatide, no fracture difference was shown. The older drug ran as an open-label group, and the fracture comparison was not significant (p = 0.44) [4].
- Men have bone-density data only. The trial in 228 men measured density, not fractures, and only the United States approves the drug for men [8], [2].
- A bone-cancer warning remains. Rats developed osteosarcoma, a bone tumour, more often at higher exposure. The American boxed warning went in December 2021, but the warning itself stayed, and Europe caps total treatment at 18 months [2], [9], [5].
What it is
Abaloparatide is a synthetic peptide of 34 amino acids. It is modelled on the front section of parathyroid hormone-related protein (PTHrP), a natural signalling molecule, with several building blocks swapped. It belongs to the small group of osteoporosis drugs that build new bone rather than only slowing the loss of old bone [2].
It was developed by Radius Health in the United States under the code BA058. It is sold as Tymlos in the United States and Switzerland, as Eladynos in the European Union, the United Kingdom and Australia, and as Ostabalo in Japan [10], [7], [11], [12].
Quick facts
| Field | Value | Ref |
|---|---|---|
| Name | Abaloparatide (international non-proprietary name); German spelling Abaloparatid | [2], [13] |
| Development codes | BA058, BA-058, BIM-44058 | [3], [14] |
| Class | Analogue of parathyroid hormone-related protein; builds bone (osteoanabolic) | [2] |
| Target | Parathyroid hormone type 1 receptor (PTH1R) | [2] |
| Structure | 34 amino acids with an amidated end; one non-standard building block (Aib) at position 29 | [2] |
| Similarity | 41 per cent shared with PTH(1-34), 76 per cent with PTHrP(1-34) | [2] |
| Formula and mass | C174H300N56O49, 3961 Da | [2], [14] |
| Half-life | About 1 hour | [2] |
| Status | Prescription-only in the US, EU, UK, Switzerland, Australia and Japan; not approved in Canada | [10], [7], [15] |
| First approval | United States, 28 April 2017 | [10] |
| ATC code | H05AA04 | [16] |
| CAS number | 247062-33-5 | [17] |
| PubChem CID | 76943386 | [14] |
| UNII | AVK0I6HY2U | [17] |
| DrugBank | DB05084 | [17] |
| ChEMBL | CHEMBL3301581 | [18] |
| InChIKey | BVISQZFBLRSESR-XSCWXTNMSA-N | [17] |
How it works
Abaloparatide switches on the same receptor as the body's own parathyroid hormone, but only for a short time. That brief, repeated signal tips the balance of bone turnover towards building [2], [5].
- One receptor. It binds the parathyroid hormone type 1 receptor (PTH1R) on bone cells [2].
- Bone-building cells speed up. Osteoblasts, the cells that lay down new bone, become more active in both the spongy inner bone and the dense outer shell [2].
- Bone removal rises only a little. The European product information describes "transient and limited increases in bone resorption", resorption being the removal of old bone [5].
- Blood markers show the imbalance. A bone-building marker peaked 93 per cent above baseline, a bone-removal marker only 26 per cent [2].
- It is gone quickly. Blood levels halve in about an hour, and the kidneys clear the fragments [2].
Bisphosphonates and denosumab work the other way round, by slowing bone removal [4], [2].
What the trials found
Almost everything rests on one trial, ACTIVE. From 2011 to 2014 it randomised 2,463 postmenopausal women with osteoporosis, aged 49 to 86, in 10 countries. Abaloparatide and placebo were compared double-blind for 18 months; a third group knew it was receiving teriparatide [3], [1].
A fracture is a hard endpoint, the event people actually want to avoid. Bone density on a scan is only a stand-in (a surrogate endpoint). A gain in density does not by itself prove that fewer bones break. That is why the approval for women rests on fractures, and the American approval for men only on density.
Randomised phase 3 trial in postmenopausal women with osteoporosis; women with X-rays that could be assessed: 690 on abaloparatide, 711 on placebo, 717 on teriparatide. Abaloparatide and placebo were double-blind, teriparatide was given openly. Most fractures were found on X-ray rather than felt. Sources [1], [2], [3].
Spine fractures
Phase 3 RCT A new spine fracture appeared in 4 of 690 women on abaloparatide (0.6 per cent) and 30 of 711 on placebo (4.2 per cent). The absolute difference was 3.6 percentage points (95 per cent confidence interval 2.1 to 5.4), a relative reduction of 86 per cent (61 to 95; p < 0.0001) [2], [3], [1].
On open-label teriparatide the figure was 6 of 717 (0.8 per cent). Most fractures were morphometric, a change of vertebral shape on X-ray that need not cause pain, and the event numbers were small [3], [4].
Phase 3 RCT, European reanalysis When European regulators excluded two centres, leaving 2,070 women, the spine result stood: 3 of 583 (0.5 per cent) on abaloparatide against 25 of 600 (4.2 per cent) on placebo [5].
Fractures away from the spine
Phase 3 RCT This was a secondary endpoint. Counting all centres, the American regulator found at least one such fracture in 2.2 per cent on abaloparatide against 4.0 per cent on placebo. The hazard ratio was 0.57 (95 per cent confidence interval 0.32 to 1.00; p = 0.049) [4].
That means a risk about 43 per cent lower. But the upper limit sits exactly at 1.00, the value that means no difference, so the result only just cleared the bar. The American label, using a different estimate over 19 months, gives 2.7 against 4.7 per cent [4], [2].
Phase 3 RCT, European reanalysis Europe removed two centres whose breaches of good clinical practice (GCP, the international rules for running trials) made their data unreliable. The rates then were 2.7 per cent on abaloparatide and 3.6 per cent on placebo [5].
The difference of 0.9 percentage points (95 per cent confidence interval -1.1 to 2.9) was "not statistically different compared to placebo". This was the main reason for the European refusal in 2019 [5], [6].
Estimated share of women with at least one non-vertebral fracture. All centres, as in the American label: hazard ratio 0.57, upper confidence limit 1.00, p = 0.049. Two centres with trial-conduct breaches excluded, as in the European product information: difference 0.9 percentage points, not statistically significant. Sources [2], [4], [5].
Hip fractures
Phase 3 RCT ACTIVE recorded only two hip fractures, both on placebo. The American regulator wrote that the trial "was underpowered to show an effect on hip fractures", meaning too small to detect one, and that the extent of any hip benefit "is unknown" [4].
No randomised trial has closed that gap. A 2025 network meta-analysis, which pools many trials, found no difference against placebo in hip fracture risk for this drug class [19].
After switching to alendronate
Phase 3 extension ACTIVExtend moved 1,139 women from the abaloparatide and placebo groups, 92 per cent of those who finished ACTIVE, onto alendronate, a bisphosphonate tablet, for 24 months. Everyone knew what they were taking [20], [21].
Over 43 months, a new spine fracture appeared in 3 of 544 women from the former abaloparatide group (0.9 per cent) and 25 of 568 from the former placebo group (5.6 per cent), p < 0.001. Only women who completed the first trial took part, which may favour healthier participants [21], [20].
Bone density in women
Phase 3 RCT, surrogate After 18 months, spine density rose by an average of 9.2 per cent on abaloparatide against 0.5 per cent on placebo. Total hip density changed by 3.4 against -0.1 per cent, each difference with p < 0.0001 [2].
Men
Phase 3 RCT, surrogate The ATOM trial randomised 228 men with osteoporosis, aged 42 to 85, two to one to abaloparatide or placebo for 12 months. Spine density rose 8.48 against 1.17 per cent (difference 7.32; 95 per cent confidence interval 5.07 to 9.57), total hip density 2.14 against 0.01 per cent [8], [22].
ATOM was not designed to count fractures. The American indication for men, added in December 2022, therefore reads only "to increase bone density". Europe, the United Kingdom and Australia approve the drug for postmenopausal women only [23], [5], [24], [25].
Against teriparatide
Phase 3 RCT, open comparator No fracture difference was shown. The time to a first fracture away from the spine had a hazard ratio of 0.79 (95 per cent confidence interval 0.43 to 1.45; p = 0.44). At 18 months hip density was higher on abaloparatide, spine density did not differ (p = 0.8155) [4], [3].
High blood calcium was less frequent on abaloparatide, 3.4 against 6.4 per cent (p = 0.006). Two limits apply: the teriparatide group was not blinded, and the trial was never sized to compare fractures between the two drugs [4].
Real-world data
Observational For the second European application, the manufacturer compared American insurance claims of 11,027 matched women per drug over 19 months. Fractures away from the spine numbered 313 on abaloparatide against 333 on teriparatide, a hazard ratio of 0.94 (0.81 to 1.10) [26], [27].
That met the pre-set test for "not worse" (upper limit below 1.3). A combined heart endpoint counted 221 against 211, a hazard ratio of 1.08 (0.89 to 1.30). Claims data cannot rule out hidden differences between the groups, and the analysis came from the manufacturer [26], [27].
The patch that missed its target
Phase 3 RCT, missed The wearABLe trial compared a microneedle skin patch with the injection in 511 postmenopausal women for 12 months. The patch was allowed to fall at most 2.0 percentage points behind in spine density gain [28].
Spine density rose 7.14 per cent with the patch and 10.86 per cent with the injection, a difference of -3.72 points (95 per cent confidence interval -5.01 to -2.43). The patch therefore failed, and it is approved nowhere [28].
What is still unknown
- Fractures in men. No trial in men has counted them [8], [2].
- Hip fractures. No randomised trial has shown a reduction [4].
- Blinded fracture comparisons. None exist against teriparatide, romosozumab or denosumab [4].
- Long-term safety. There are no data beyond two years of treatment, and no bone-cancer registry study of abaloparatide itself [2].
- Certain groups. There are no data in liver impairment, in children or in pregnancy [2], [5].
Side effects and safety
American label figures, abaloparatide against placebo, in women unless men are named [2].
- Injection-site reactions. Redness in 58 against 28 per cent in the first month, swelling 11 against 3, pain 10 against 7 [2].
- Dizziness. 10 against 6 per cent in women and 9 against 1 per cent in men [2].
- Nausea and headache. Nausea 8 against 3 per cent, headache 8 against 6 [2].
- A pounding or racing heart. Palpitations 5 against 0.4 per cent, fast heart rate (tachycardia) 2 against 1 per cent [2].
- Calcium. Extra calcium in the urine 11 against 9 per cent, high blood calcium 3 against 0.1 per cent, kidney stones 2.1 against 1.7 per cent [2].
- Uric acid. Raised above the normal range in 25 against 6 per cent, without more gout [2].
- Antibodies. 42.9 per cent formed antibodies against the drug by 18 months [5].
Serious events In ACTIVE, serious adverse events affected 10 per cent on abaloparatide and on teriparatide, and 11 per cent on placebo. Stopping because of side effects was more common on abaloparatide: 10 per cent, against 7 on teriparatide and 6 on placebo. The main reasons were nausea, dizziness, headache and palpitations [4], [29].
Heart and blood pressure An hour after the first injection, heart rate rose by an average of 7.9 beats per minute, against 5.3 on teriparatide and 1.2 on placebo [29]. The American label warns of a drop in blood pressure on standing up and a faster heartbeat, usually within four hours of an injection [2].
European regulators saw a heart safety problem in 2018. The current European product information requires blood pressure, heart status and an ECG to be checked before treatment starts [6], [5].
Who must not use it In the United States the only contraindication is a serious allergy, added in August 2026, when the label also began listing anaphylaxis and hives. Europe, the United Kingdom and Australia list many more [2], [5], [24], [25]:
- pregnancy, breastfeeding and women who could become pregnant;
- existing high blood calcium or severe kidney impairment;
- unexplained raised alkaline phosphatase, an enzyme linked to bone turnover;
- a known higher risk of osteosarcoma, such as earlier radiotherapy of the skeleton;
- bone tumours or bone metastases.
The bone-cancer question
Animal data In a two-year study in rats, osteosarcoma rose with the amount given, at exposures 4 to 28 times those in humans. It affected 35, 57 and 74 per cent of animals in the three dose groups, against 2 per cent of controls [2], [4], [30].
A comparison group given the teriparatide fragment reached 53 per cent. Because its exposure was not measured, the study cannot show which drug carries the stronger signal [4], [30].
No case appeared in ACTIVE or its extension. The regulator did not read that as reassurance: "This is not surprising – even if abaloparatide increased the risk for osteosarcoma – given the rarity of the tumor" [4].
The American warning has changed in form, not in substance:
- 2017. Approval came with a boxed warning, "Warning: risk of osteosarcoma", and advice against use of this drug and similar hormone fragments for more than two years in a lifetime [31].
- December 2021. The boxed warning, the most prominent kind on an American label, was removed [9].
- Today. The osteosarcoma warning and the two-year lifetime limit remain in the label. It states that it is unknown whether the drug causes osteosarcoma in humans [2].
The label adds that osteosarcoma has been reported after marketing in patients treated with a parathyroid hormone analogue. Observational studies in humans have not shown an increased risk, but data beyond two years are limited [2].
Those human studies concern mainly teriparatide. No registry study of abaloparatide itself has been found, so the question of human risk remains open [2], [32].
Outside the United States there was never a boxed warning, but there is a hard cap. Europe, the United Kingdom and Australia limit total treatment to 18 months, citing the rat studies, and the Japanese licence holder states the same [5], [24], [25], [12].
The American label also names people whose bone-cancer risk is already higher and who should avoid the drug. They include people with open growth plates, Paget disease or other metabolic bone disease, bone metastases or past bone tumours, earlier radiotherapy of the skeleton, or an inherited predisposition [2].
Why this page lists no doses
This page gives no amounts of abaloparatide, no schedule and no injection instructions, because it is a prescription medicine wherever it is approved. The time limits named above are regulatory safety limits tied to the rat findings, not a treatment plan [2], [5].
Development and approval status
Abaloparatide has been an approved prescription medicine in the United States since April 2017. Of the seven markets this register checks, only Canada has not approved it. All checks were run on 23 September 2026 [10], [15].
From a phase 3 trial to six approvals, with one refusal on the way
- 2011-2014ACTIVE runs2,463 women in 10 countries, 18 months, ref [3]
- 2016Fracture results publishedNew spine fractures 0.6 against 4.2 per cent, ref [1]
- 2017American approvalApproved on 28 April with a boxed osteosarcoma warning, refs [10], [31]
- 2019European refusalRejected on 7 January over fractures away from the spine, trial conduct and the heart, ref [6]
- 2021Japan; boxed format droppedLaunched in Japan in March; American boxed warning removed in December, the osteosarcoma warning stays in the label, refs [12], [9]
- 2022Europe approves, America adds menEU approval on 12 December; American indication for men on 19 December, refs [7], [10]
- 2023United KingdomLicensed on 27 March, relying on the EU decision, ref [33]
- 2024Switzerland and AustraliaApproved on 7 March and 28 November, refs [11], [25]
- 2026Allergy warning addedAmerican label updated in August, ref [2]
- 2017 American approval with a boxed warning [10], [31].
- 2019 European refusal after a negative opinion in 2018 [6].
- 2021 Japanese launch; American boxed format dropped, warning kept [12], [9].
- 2022 European approval; American indication for men [7], [10].
- 2023 and 2024 United Kingdom, Switzerland and Australia [33], [11], [25].
- 2025 Swiss application for men filed, outcome open [34].
| Market | Status | Since or note |
|---|---|---|
| United States | Approved | 2017 |
| European Union | Approved | 2022 |
| Germany | Approved | Prescription-only |
| United Kingdom | Approved | 2023 |
| Australia | Approved | 2024 |
| Canada | Unapproved | No record |
| Switzerland | Approved | 2024 |
Europe, second attempt. The 2019 refusal cited the fractures away from the spine, unreliable data from two centres, and heart rate and palpitations. The committee "could not identify a group of patients in whom the benefits would outweigh the risks". A new licence holder applied again with American real-world data and was approved in December 2022 [6], [7], [27].
The other markets. The United Kingdom relied on the European decision [33]. Switzerland lists the drug in prescription category B [11], and Germany names it in the annex of its prescription regulation [13]. The Australian register was unreachable, so the status rests on the Australian product information, which lists it as prescription-only (Schedule 4) [25], [35].
The Japanese status rests only on the licence holder's announcement [12]. Canada's drug database returned nothing [15].
Research and grey market. The trial registry lists 25 studies, including copies in phase 3 testing in South Korea and China [36], [37]. No official warning checked names abaloparatide, including three American warning letters to online peptide sellers and three Canadian alerts from 2026 [38], [39], [40], [41].
That was not a complete search, so a grey market is undocumented rather than ruled out. The wider legal picture is under are peptides legal and FDA-approved peptides.
Anti-doping
Abaloparatide is not on the 2026 prohibited list. A full-text search found no match for it, teriparatide or parathyroid hormone [42].
The peptide hormone class S2 does not list parathyroid hormone or its analogues, though only the anti-doping agency can rule on its catch-all wording. The class for non-approved substances, S0, does not apply to an approved medicine [42].
The German anti-doping act does not name it either [43]. This says nothing about safety; the full picture is at peptides banned in sport.
Compared with related peptides
| Substance | What it is | Status | Fracture or trial result on record | Ref |
|---|---|---|---|---|
| Abaloparatide | Analogue of PTHrP(1-34), acts at PTH1R | Approved since 2017 | New spine fractures 0.6 against 4.2 per cent on placebo | [2] |
| Teriparatide | Fragment 1-34 of parathyroid hormone, acts at PTH1R | Approved; ATC H05AA02 | Open-label arm in ACTIVE: new spine fractures 0.8 per cent | [3] |
| Parathyroid hormone | The natural hormone | ATC H05AA03 | Hormone replacement, not an osteoporosis comparison | [16] |
| Palopegteriparatide | Teriparatide-based hormone replacement | ATC H05AA05 | Treats underactive parathyroid glands, not osteoporosis | [16] |
All four share a drug group and a receptor, but only abaloparatide and teriparatide are osteoporosis drugs [16]. Teriparatide, which has its own page, is the only close comparison. In ACTIVE no fracture difference between the two was shown, the teriparatide group was not blinded, and high blood calcium was less frequent on abaloparatide [4].
Their warnings diverged later. America removed both boxed warnings but kept the two-year lifetime limit only for abaloparatide. Europe caps abaloparatide at 18 months and teriparatide at 24 [2], [44], [5], [45].
Common misconceptions
- "Abaloparatide is teriparatide under another name." Teriparatide is a fragment of parathyroid hormone; abaloparatide is an altered fragment of the related protein PTHrP, with its own classification code [2], [16].
- "Removing the boxed warning settled the bone-cancer question." It did not. The warning and the two-year lifetime limit remain in the American label, Europe keeps its 18-month cap, and the human data come mainly from teriparatide [2], [5].
- "The approval for men shows fewer fractures in men." It shows higher bone density. The men's trial did not count fractures [2], [8].
- "The trial proved it beats teriparatide." For fractures, no difference was shown, and the teriparatide group was open-label [4].
Frequently asked questions
What is abaloparatide?
It is a synthetic peptide of 34 amino acids, modelled on a fragment of parathyroid hormone-related protein. It stimulates the cells that build bone.
Where is abaloparatide approved?
It is a prescription medicine in the United States, the European Union, the United Kingdom, Switzerland, Australia and, according to the licence holder, Japan. Canada has not approved it.
What did the main abaloparatide trial show?
In the ACTIVE trial, new spine fractures seen on X-ray affected 0.6 per cent of women on abaloparatide against 4.2 per cent on placebo over 18 months. The result for fractures away from the spine was borderline and not significant once two problem centres were excluded.
Does abaloparatide prevent hip fractures?
That has not been shown. The main trial recorded only two hip fractures, both on placebo, and the American regulator called the extent of any hip benefit unknown.
Why did Europe refuse abaloparatide at first?
The European Commission refused it in January 2019. The reasons were fractures away from the spine, unreliable data from two centres, and heart effects. A second application with real-world data was approved in December 2022.
Does abaloparatide cause bone cancer?
It is not known. In rats it caused osteosarcoma more often at higher exposure, and the American label still warns about it, although the boxed format was dropped in 2021. Human data come mainly from teriparatide and are limited beyond two years, and Europe caps treatment at 18 months for this reason.
Is abaloparatide approved for men?
Only in the United States, and only "to increase bone density". The trial in 228 men measured density, not fractures.
How does abaloparatide differ from teriparatide?
Teriparatide is a fragment of parathyroid hormone; abaloparatide imitates the related protein PTHrP. Both act on the same receptor. In the main trial no fracture difference between them was shown, and teriparatide was given openly.
Is abaloparatide banned in sport?
No. It is not on the 2026 prohibited list, and the German anti-doping act does not list it either. That says nothing about safety and does not change its prescription-only status.
Sources
- Miller PD, Hattersley G, Riis BJ, et al. (2016). Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 316(7):722-733. PMID 27533157. DOI 10.1001/jama.2016.11136. Abstract read; the full text returned an access error.
- Radius Health. Abaloparatide injection, United States prescribing information, label version 19, effective 11 August 2026. DailyMed set id 712143d9-e21e-4013-bb3b-3426a21060a8. Sections 1, 4, 5, 6.1, 8, 11, 12, 13.1 and 14. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8
- ClinicalTrials.gov. NCT01343004, ACTIVE, study BA058-05-003, phase 3, 2,463 participants, March 2011 to October 2014, posted results for fractures, bone density and serious adverse events. Queried via API v2. https://clinicaltrials.gov/study/NCT01343004
- Joffe HV, Center for Drug Evaluation and Research, US Food and Drug Administration (2017). Summary review for NDA 208743, 27 April 2017: benefit and risk, fracture analyses, hazard ratios for non-vertebral fractures, the comparison with teriparatide, rat carcinogenicity and the reasons for the boxed warning. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000SumR.pdf
- Theramex Ireland (2024). Abaloparatide, EU summary of product characteristics, sections 4.2, 4.3, 4.4, 4.8 and 5.1, including the fracture table without the two excluded centres. https://www.ema.europa.eu/en/documents/product-information/eladynos-epar-product-information_en.pdf
- European Medicines Agency. Refusal of the marketing authorisation for abaloparatide, EMEA/H/C/004157 (Radius Health): negative opinion 22 March 2018, confirmed on re-examination 26 July 2018, refusal by the European Commission 7 January 2019, with the reasons given. https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos-0
- European Medicines Agency. European public assessment report for abaloparatide, EMEA/H/C/005928, licence holder Theramex Ireland; committee opinion 13 October 2022, EU authorisation 12 December 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/eladynos
- Czerwinski E, Cardona J, Plebanski R, et al. (2022). The efficacy and safety of abaloparatide-SC in men with osteoporosis: a randomized clinical trial. Journal of Bone and Mineral Research 37(12):2435-2442. PMID 36190391.
- Radius Health (2021). Abaloparatide, United States prescribing information, supplement S-010, listing "Osteosarcoma Boxed Warning, Removed 12/2021" under recent major changes. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf
- US Food and Drug Administration. Drugs@FDA, application NDA 208743, submission history from the original approval of 28 April 2017 (new molecular entity) to supplement 18 of 3 August 2026, including supplement 13 of 19 December 2022 (indication in men). Queried via openFDA on 23 September 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208743
- Swissmedic. Extended list of authorised human medicines, status 31 August 2026: authorisation number 69246, holder Labatec Pharma SA, first authorised 7 March 2024, dispensing category B, ATC H05AA04. https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx
- Teijin Pharma (2021). News release: Teijin to commence manufacture and sale in Japan of abaloparatide acetate, 23 March 2021, including the indication wording and the 18-month limit. A licence holder's statement, not a regulator's document. https://www.teijin.com/news/2021/03/23/20210323_01.pdf
- Germany, Arzneimittelverschreibungsverordnung (prescription regulation), annex 1, full text checked 23 September 2026: "Abaloparatid" is listed by name. https://www.gesetze-im-internet.de/amvv/anlage_1.html
- PubChem. Compound CID 76943386, abaloparatide: properties and synonyms, including BIM-44058 and BA-058. https://pubchem.ncbi.nlm.nih.gov/compound/76943386
- Health Canada, Drug Product Database API, queried 23 September 2026: active ingredient "abaloparatide" returned 0 records and both trade names returned empty results, against 7 records for the control search "teriparatide". https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=abaloparatide&lang=en&type=json
- WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD index, group H05AA parathyroid hormones and analogues: H05AA02 teriparatide, H05AA03 parathyroid hormone, H05AA04 abaloparatide, H05AA05 palopegteriparatide. https://atcddd.fhi.no/atc_ddd_index/?code=H05AA
- Wikidata. Item Q4834481, abaloparatide: CAS number, UNII, InChIKey and DrugBank identifier. https://www.wikidata.org/wiki/Q4834481
- ChEMBL. Molecule CHEMBL3301581, abaloparatide. https://www.ebi.ac.uk/chembl/api/data/molecule/search.json?q=abaloparatide
- Beaudart C, Veronese N, Douxfils J, et al. (2025). PTH1 receptor agonists for fracture risk: a systematic review and network meta-analysis. Osteoporosis International 36(6):951-967. PMID 40047881. 17 studies, 11 of them randomised; several authors report fees from the licence holders.
- ClinicalTrials.gov. NCT01657162, ACTIVExtend, study BA058-05-005, 1,139 participants, posted results. Queried via API v2. https://clinicaltrials.gov/study/NCT01657162
- Bone HG, Cosman F, Miller PD, et al. (2018). ACTIVExtend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis. Journal of Clinical Endocrinology and Metabolism 103(8):2949-2957. PMID 29800372.
- ClinicalTrials.gov. NCT03512262, ATOM, phase 3 in 228 men, completed September 2021, posted results. Queried via API v2. https://clinicaltrials.gov/study/NCT03512262
- Radius Health (2022). Abaloparatide, United States prescribing information, supplement S-013, adding the indication in men, December 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208743s013lbl.pdf
- Theramex Ireland (2024). Abaloparatide, United Kingdom summary of product characteristics, licence PLGB 49876/0025, with the 18-month maximum. https://mhraproducts4853.blob.core.windows.net/docs/da43e26e45fd434280b75d1df49b9a6ff4220ff3
- Theramex Australia (2024). Abaloparatide, Australian product information: prescription-only medicine (Schedule 4), date of first approval 28 November 2024, 18-month maximum, contraindications. https://medsinfo.com.au/api/documents/Eladynos_PI?format=pdf
- ClinicalTrials.gov. NCT04974723, retrospective matched cohort of abaloparatide against teriparatide in American claims data, 22,054 women, posted results. https://clinicaltrials.gov/study/NCT04974723
- Davenport C, Gravel P, Wang Y, et al. (2024). Real-world evidence to support the registration of a new osteoporosis medicinal product in Europe. Therapeutic Innovation & Regulatory Science 58(3):505-518. PMID 38341388. Most authors were employees of or consultants to the developer.
- ClinicalTrials.gov. NCT04064411, wearABLe, phase 3 comparison of a microneedle patch with the injection in 511 women, completed November 2021, posted results; non-inferiority not met. https://clinicaltrials.gov/study/NCT04064411
- Cosman F, Peterson LR, Towler DA, et al. (2020). Cardiovascular safety of abaloparatide in postmenopausal women with osteoporosis: analysis from the ACTIVE phase 3 trial. Journal of Clinical Endocrinology and Metabolism 105(11):3384-3395. PMID 32658264.
- Jolette J, Attalla B, Varela A, et al. (2017). Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34). Regulatory Toxicology and Pharmacology 86:356-365. PMID 28389324.
- Radius Health (2017). Abaloparatide, United States prescribing information, first version, with the boxed warning "Warning: risk of osteosarcoma" and the two-year lifetime advice. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf
- Krege JH, Gilsenan AW, Komacko JL, Kellier-Steele N (2022). Teriparatide and osteosarcoma risk: history, science, elimination of boxed warning, and other label updates. JBMR Plus 6(9):e10665. PMID 36111201.
- Medicines and Healthcare products Regulatory Agency (2023). Public assessment report for abaloparatide, PLGB 56979/0001, granted 27 March 2023 under the EC Decision Reliance Procedure. https://mhraproducts4853.blob.core.windows.net/docs/0e669c844f46a30bd91b0ef8178eb5c730034c8c
- Swissmedic. List of incoming applications for human medicines: application received 29 October 2025 for a new indication in men with osteoporosis; outcome open. https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/gesuchseingaenge-ham.xlsx.download.xlsx/Gesuchseing%C3%A4nge%20HAM_31012021.xlsx
- Therapeutic Goods Administration, Australian Register of Therapeutic Goods entry 430937 and public assessment report. Not reachable on 23 September 2026 (time-out); the entry number is known only from search-engine data. https://www.tga.gov.au/resources/artg/430937
- ClinicalTrials.gov, all records for abaloparatide, queried via API v2 on 23 September 2026: 25 studies, 11 of them sponsored by the original developer, including academic studies in fracture healing, before spinal fusion and knee replacement, and in combination with denosumab.
- ClinicalTrials.gov. NCT06154187 (phase 3 bridging study in South Korea) and NCT06898060 (phase 3 study of a Chinese abaloparatide injection against teriparatide), study descriptions queried via API v2 on 23 September 2026. https://clinicaltrials.gov/study/NCT06898060
- US Food and Drug Administration. Warning letter to Peptide Partners LLC, 735063, 24 August 2026; no mention of abaloparatide. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026
- US Food and Drug Administration. Warning letter to Wholesale Peptide, 729447, 17 June 2026; no mention of abaloparatide. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026
- US Food and Drug Administration. Warning letter to Gram Peptides, 721806, 31 March 2026; no mention of abaloparatide. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026
- Health Canada. "Think twice before injecting peptides bought online", 9 April 2026, and two related product alerts; no mention of abaloparatide. https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm
- World Anti-Doping Agency. The 2026 Prohibited List, classes S0 and S2. Full text searched on 23 September 2026: no match for abaloparatide, teriparatide, parathyroid, PTHrP or PTH, against matches for the control terms tesamorelin, somatrogon and kisspeptin. https://www.wada-ama.org/en/prohibited-list
- Annex to the German anti-doping act, BGBl. 2023 I no. 67, full text checked 23 September 2026: no entry for abaloparatide, teriparatide or parathyroid hormone, against entries for the control terms tesamorelin and somatrogon. https://www.gesetze-im-internet.de/antidopg/anlage.html
- Eli Lilly (2026). Teriparatide, United States prescribing information, supplement S-059, current wording on use beyond two years in a lifetime. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021318Orig1s059lbl.pdf
- Eli Lilly (2026). Teriparatide, EU product information, with the 24-month maximum treatment duration. https://www.ema.europa.eu/en/documents/product-information/forsteo-epar-product-information_en.pdf
Cite this page
The facts on this page were checked on 23 September 2026. Three points rest on second-best evidence: the Australian register was unreachable, the Japanese status comes from the licence holder, and the full text of the main trial paper could not be retrieved.
myPeptides Research & Editing. (2026). Abaloparatide: what the trials show, status and safety. Version 1.0, 24 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/abaloparatide
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.
| Version | Date | Change |
|---|---|---|
| 1.0 | 2026-09-24 | Initial publication |
Last verified: 23 September 2026. Next review: on any Swiss decision about men, on any new fracture trial, or on any change to the osteosarcoma wording in a label.