As of September 2026, abaloparatide is an approved medicine for osteoporosis in the US and the EU. The US approval is for osteoporosis at high fracture risk. The record says its label carries a boxed warning about a bone-tumor signal seen in rats. Human data have not confirmed that risk. If a vial of abaloparatide reached you outside a pharmacy, you cannot tell from the outside what it holds.
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What is abaloparatide?
Abaloparatide is a lab-made peptide built to mimic part of PTHrP, a natural human protein that stimulates bone-building cells. Radius Health developed it. The FDA approved it in 2017 for postmenopausal women with osteoporosis at high fracture risk, and extended the approval to men in 2022.
Does abaloparatide work?
The FDA reviewed the trials and approved it for osteoporosis at high fracture risk. The 2017 approval was based on ACTIVE, a Phase 3 trial that compared it with placebo.
What we found. 4+ completed randomized trials counted on the record. 3 study rows listed below, and only the first names a single trial, so the number shows with a plus sign until every trial is listed.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| ACTIVE trial (Phase 3), NCT01343004 on ClinicalTrials.gov (opens in new tab) | People | Published 2016 | Lower risk of spine fractures and of other fractures than placebo. The basis for the 2017 approval |
| Review of abaloparatide's efficacy and safety | People | Published 2019 | A review. It pulls together data from ACTIVE and from its extension |
| Approval program for men with osteoporosis | People | Approved 2022 | It supported adding men with osteoporosis at high fracture risk to the label |
Is abaloparatide safe?
In people, the data have not confirmed a bone-tumor risk. The concern comes from rat studies, which showed a higher risk of osteosarcoma, a bone tumor, at high, long-term exposure. The record says the label carries a boxed warning for it. Human cancer tracking beyond the approved treatment length is limited, so the question is not fully resolved. Those findings belong to Tymlos as a pharmacy supplies it. A vial from elsewhere gets its own section below.
Is abaloparatide legal?
- United States
- Approved by the FDA as Tymlos for osteoporosis at high fracture risk, in 2017 for postmenopausal women and in 2022 for men.
- European Union
- Approved by the EMA for osteoporosis. The record gives no year and no brand name.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as abaloparatide?
The trials above supported the approval of Tymlos, the maker's product. Nothing on this record shows abaloparatide being sold outside pharmacies. A vial that reached you some other way was not in any of those studies. The checklist lists what to ask whoever sold it.
What don't we know?
- Whether the bone-tumor signal seen in rats applies to people. Human data have not confirmed it.
- What long-term cancer tracking in people will show. Data beyond the approved treatment length are limited.
- What is in any vial that did not come from a pharmacy.
The other side
Abaloparatide comes with a prescription and a doctor's care. The record says its users have already had a fracture or face a very high risk of one. The main safety concern on the record is a signal in rats that human data have not confirmed.
What would change this record?
- Large, long-running tracking of osteosarcoma in people who used the medicine after approval. The record says it would most directly settle the doubt behind the warning.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about abaloparatide
Is abaloparatide the same as Tymlos?
- Tymlos is the brand name the FDA approved for abaloparatide.
What is abaloparatide approved for?
- Osteoporosis. In the US the approval is for people at high fracture risk: postmenopausal women since 2017 and men since 2022.
Does abaloparatide cause bone cancer in people?
- That is not fully resolved. Rat studies showed a higher risk of osteosarcoma at high, long-term exposure. Human data have not confirmed the risk, and long-term cancer tracking in people is limited.
Is abaloparatide the same as teriparatide?
- No. Abaloparatide mimics part of a protein called PTHrP. Teriparatide is a lab-made copy of part of parathyroid hormone. The record calls the two related and says they share the same main safety concern.
Has abaloparatide been tested in men?
- Yes. The record lists an approval program for men, and the FDA extended the approval to men in 2022.
Record checked on . Each source shows the date it was checked.
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