Summary
Abaloparatide is a lab-made version of parathyroid hormone related protein that, injected daily, stimulates new bone formation; it was FDA approved as Tymlos in 2017 for postmenopausal women with osteoporosis (thin, fragile bones) at high fracture risk and in 2022 for men. In the 18 month ACTIVE trial of 2,463 women, 80 micrograms daily reduced new vertebral (spine) fractures from 4.22% to 0.58% and nonvertebral fractures (breaks elsewhere in the skeleton) by 43% versus placebo, with less hypercalcemia (too much calcium in the blood) than teriparatide. It is a prescription drug and is not compounded (custom-made by pharmacies).
What is Abaloparatide?
Abaloparatide is a synthetic 34 amino acid analog of parathyroid hormone related protein (PTHrP), a bone anabolic agent. It is also known as Tymlos, BA058, PTHrP (1-34) analog, Abaloparatide-SC.
How does it work?
Abaloparatide is a selective activator of the PTH1 receptor that preferentially binds the transient RG conformation, producing a shorter signaling burst than teriparatide. Daily pulses stimulate osteoblast bone formation with a smaller rise in bone resorption and serum calcium. Bone density rises fastest in the first 6 months, and treatment is followed by an antiresorptive to preserve the gain.
| Cluster | Other peptides |
|---|---|
| Routes | Subcutaneous injection once daily (prefilled pen) |
| Conditions studied | Osteoporosis |
| Record | v3, draft, verified Sep 23, 2026 |
FDA-approved uses of Abaloparatide
Yes. The Tymlos label covers two uses: treatment of postmenopausal women with osteoporosis (bones thin and fragile enough to break easily) at high risk for fracture (a history of osteoporotic fracture or multiple risk factors) or who have failed or cannot tolerate other osteoporosis therapy, and treatment to increase bone density in men with osteoporosis at high risk for fracture on the same terms. It was approved in 2017, with the men's indication added in 2022. It is prescription only. [3]
What does the evidence say about Abaloparatide?
One large placebo and active controlled RCT plus an extension. ACTIVE (Miller 2016, n = 2,463): new vertebral fractures 0.58% with abaloparatide versus 4.22% with placebo (relative risk reduction 86%) and 0.84% with open label teriparatide; nonvertebral fractures 2.7% versus 4.7% (hazard ratio 0.57); hypercalcemia 3.4% versus 6.4% with teriparatide. ACTIVExtend (Cosman 2017): 18 months of abaloparatide followed by 6 months of alendronate kept vertebral fracture risk reduction at 87% versus the placebo to alendronate arm.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 2 | 2463 |
| Human observational studies | 0 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 2 | 2,463 |
Human evidence
ACTIVE: 2,463 postmenopausal women with osteoporosis randomized to abaloparatide 80 ug daily, placebo, or open label teriparatide 20 ug daily for 18 months. New morphometric vertebral fractures: 0.58% abaloparatide, 4.22% placebo, 0.84% teriparatide. Nonvertebral fractures: 2.7% versus 4.7% placebo (hazard ratio 0.57, 95% CI 0.32 to 1.00). Lumbar spine BMD rose 11.2% versus 0.6% placebo. ACTIVExtend: after switching all participants to alendronate for 6 months, cumulative new vertebral fracture incidence remained lower in the abaloparatide sequence (0.55% versus 4.4%). The 2022 male indication rested on a 228 patient BMD trial.
Animal evidence
Rats given abaloparatide for 2 years showed a dose dependent increase in osteosarcoma, as with teriparatide. No osteosarcoma has been observed in humans; FDA removed the boxed warning in December 2021 based on the human safety record. Monkey studies showed increased bone formation and strength.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE)2016 PMID 27533157 | Randomized, double blind, placebo controlled trial with open label teriparatide arm, 18 monthsn = 2,463 Postmenopausal women aged 49 to 86 with osteoporosis | New vertebral fractures 0.58% abaloparatide versus 4.22% placebo (86% relative reduction); nonvertebral fractures hazard ratio 0.57; hypercalcemia 3.4% versus 6.4% with teriparatide | Evidence: Human RCT evidence |
| Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial2017 PMID 28160873 | Open label extension of ACTIVE with alendronate in both arms, 6 monthsACTIVE participants from the abaloparatide and placebo arms | Cumulative new vertebral fracture incidence 0.55% in the abaloparatide to alendronate sequence versus 4.4% in placebo to alendronate (87% relative reduction) | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Osteoporosis | Evidence: Human RCT evidence | ACTIVE (n = 2,463): new vertebral fractures 0.58% versus 4.22% on placebo, with less hypercalcemia than teriparatide; FDA approved as Tymlos. |
Is Abaloparatide legal in the United States?
FDA and compounding status
FDA approved as Tymlos in April 2017 for postmenopausal women with osteoporosis at high risk of fracture, with an expanded indication for men with osteoporosis in December 2022. In December 2021 FDA approved removal of the boxed warning for osteosarcoma and the 2 year cumulative use limit. Because an approved product exists, compounding is not permitted except for a documented patient specific need. No generic is available as of the last verified date.
WADA status
Not WADA prohibited. Not named on the current prohibited list. Athletes should still confirm against the list in force for their season.
Regulatory timeline
- FDA
FDA approves Tymlos (abaloparatide) for postmenopausal osteoporosis
FDA approved abaloparatide injection (Tymlos), a parathyroid hormone-related protein analog, for postmenopausal women with osteoporosis at high risk of fracture.
Regulatory: FDA approvedSource: Drugs@FDA: Tymlos (abaloparatide) NDA 208743
Full tracker for Abaloparatide or the category-wide tracker.
Abaloparatide dose on the FDA label
Doses below are quoted from the FDA label for its approved uses, plus the doses used in the pivotal trials where noted. The prescriber sets the dose; PeptideAgent does not recommend doses or protocols.
FDA label (Tymlos, DailyMed): 80 mcg injected subcutaneously once daily into the periumbilical region of the abdomen, rotating the site daily, with supplemental calcium and vitamin D if dietary intake is inadequate. The first several doses are given where the patient can sit or lie down in case of orthostatic hypotension. The label notes safety and efficacy have not been evaluated beyond 2 years of treatment. The ACTIVE trial used the same 80 mcg daily dose.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous injection once daily (prefilled pen) |
What are the side effects and interactions of Abaloparatide?
Side effects
| # | Reported side effect |
|---|---|
| 1 | Hypercalciuria (11%) and hypercalcemia (3.4% versus 0.4% placebo in ACTIVE) |
| 2 | Dizziness (10%), nausea (8%), headache (8%), palpitations (5%) |
| 3 | Orthostatic hypotension, usually within 4 hours of injection |
| 4 | Injection site redness and pain |
| 5 | Osteosarcoma in rats at high lifetime doses; boxed warning removed in 2021 after no human signal |
Interactions
| # | Interaction |
|---|---|
| 1 | Digoxin: abaloparatide induced hypercalcemia may increase digoxin toxicity |
| 2 | Concurrent bisphosphonates or denosumab blunt the anabolic response; sequential use is standard |
| 3 | No formal drug interaction studies beyond these |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Hypersensitivity to abaloparatide |
| 2 | Pre-existing hypercalcemia, primary hyperparathyroidism, or hypercalcemic disorders |
| 3 | Bone metastases, skeletal malignancy, Paget disease, prior skeletal radiation, or open epiphyses (higher baseline osteosarcoma risk, per label) |
| 4 | Pregnancy and breastfeeding |
How do people access Abaloparatide legally?
Typical cost: List price roughly 2,000 to 3,000 USD per month. Most commercial plans and Medicare Part D cover it with prior authorization; a manufacturer copay program is available for commercially insured patients.
Verified access options
Step 1
Prescription from a licensed provider filled at a specialty or retail pharmacy.
Step 2
Prior authorization typically requires a prior fragility fracture, very low bone density, or intolerance to other agents.
Step 3
Not available through compounding or telehealth peptide clinics.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare Abaloparatide
Frequently asked questions
How much does abaloparatide reduce fractures?
In the ACTIVE trial of 2,463 postmenopausal women, 18 months of abaloparatide 80 ug daily reduced new vertebral fractures from 4.22% on placebo to 0.58%, an 86% relative reduction, and nonvertebral fractures from 4.7% to 2.7%. When followed by 6 months of alendronate in ACTIVExtend, the vertebral fracture reduction was maintained at 87%. [1] [2]
What are the side effects of abaloparatide?
The most common in ACTIVE were high urine calcium (11%), dizziness (10%), nausea (8%), headache (8%), and palpitations (5%). Blood calcium rose above normal in 3.4% of patients versus 6.4% on teriparatide. Orthostatic dizziness can occur within hours of injection, so the first doses are taken where the person can sit or lie down. [1] [3]
Does abaloparatide cause bone cancer?
Rats given abaloparatide for 2 years developed osteosarcoma in a dose dependent way, which produced a boxed warning at approval. No case has been linked to the drug in humans, and in December 2021 FDA removed the boxed warning and the 2 year use limit. People with Paget disease, prior bone radiation, or open growth plates are still advised to avoid it. [3]
What is the abaloparatide (Tymlos) dose on the FDA label?
80 mcg injected under the skin of the lower abdomen once a day from a prefilled pen, rotating the site every day, with calcium and vitamin D if diet falls short. The label advises giving the first several doses sitting or lying down because of orthostatic hypotension, and states that safety and efficacy were not studied beyond 2 years. In the trials, treatment was followed by an antiresorptive such as alendronate to hold the bone gain. [2] [3]
How much does abaloparatide cost?
Roughly 2,000 to 3,000 USD per month at list price, with no generic. Insurance including Medicare Part D usually covers it after prior authorization, and a manufacturer copay program exists for commercially insured patients. Prices were checked on the last verified date. [3]
Is abaloparatide banned by WADA?
No. PTH and PTHrP analogs are not named on the WADA Prohibited List. Athletes should confirm with their anti-doping organization since the list changes annually. [4]
Abaloparatide vs teriparatide: which is better?
In ACTIVE, abaloparatide and open label teriparatide had similar vertebral fracture rates (0.58% versus 0.84%), abaloparatide had fewer nonvertebral fractures numerically, and abaloparatide caused about half as much hypercalcemia (3.4% versus 6.4%). The trial was not designed to prove one superior on fractures. Teriparatide has generics and a longer track record; abaloparatide can be stored at room temperature after first use. [1] [3]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
From the blog
- Peptides for men, ranked by human evidence
hCG, GLP-1 drugs, teriparatide, and tesamorelin have human trials and a lawful route. PT-141 is off-label for men, and kisspeptin and melanotan II have no lawful path. Ranking, legality, and WADA.
- Peptides for women, ranked by human evidence
GLP-1 drugs, teriparatide, abaloparatide, and Vyleesi (PT-141) have real trials in women. Kisspeptin is research-only and GHK-Cu rests on small skin studies. The ranking and legal status.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Miller PD et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA 2016 (ACTIVE)PubMed 27533157, 2016
- [2]Cosman F et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc 2017PubMed 28160873, 2017
- [3]FDA prescribing information for Tymlos (abaloparatide) injection, via DailyMedFDA, 2026
- [4]WADA Prohibited ListWADA, 2026
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PeptideAgent. (2026, September 23). Abaloparatide: evidence, legality, and access. https://peptideagent.ai/peptides/abaloparatide- HTML link
<a href="https://peptideagent.ai/peptides/abaloparatide">Abaloparatide: evidence, legality, and access</a>, PeptideAgent, updated September 23, 2026.