At a glance
FDA approval FDA-approved 1 application
Randomized controlled trials 32 of 409 publications on PubMed
Registered clinical trials 25 7 active
Adverse event reports 29,291 4,970 classified as serious
- Abaloparatide is an FDA-approved drug, marketed as Tymlos (first approval: April 28, 2017).
- PubMed lists 409 publications mentioning it, including 32 randomized controlled trials and 45 animal-only studies.
- ClinicalTrials.gov lists 25 registered studies testing it (7 active).
- FDA's adverse event system (FAERS) holds 29,291 reports mentioning it; 4,970 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
| NDA208743 | TYMLOS | Approved, marketed | April 28, 2017 | RADIUS |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 409
- Human (MeSH) 268
- Animal only 45
- Clinical trials 37
- Randomized controlled trials 32
- Systematic reviews & meta-analyses 31
- Case reports 10
- Retracted 0
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 25
- Active
- 7
- With posted results
- 11
| Study | Status | Phase | Start |
| The Effect of Osteoporotic Medications on Vertebral Bone Quality Score NCT07587775 State University of New York at Buffalo | Enrolling by invitation | Phase 2 | June 18, 2026 |
| MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis NCT07616401 Istituto Auxologico Italiano | Recruiting | N/A | August 31, 2025 |
| To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture NCT06898060 Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | Phase 3 | Jun 2025 |
| A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects NCT06753864 The Affiliated Hospital of Qingdao University | Not yet recruiting | Phase 1 | January 2, 2025 |
| Sequential Therapies After Osteoanabolic Treatment NCT06164795 424 General Military Hospital | Recruiting | — | November 25, 2023 |
| Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone NCT04467983 Hospital for Special Surgery, New York | Active, not recruiting | Phase 4 | February 1, 2021 |
| Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery NCT03841058 Hospital for Special Surgery, New York | Active, not recruiting | Phase 2 | August 14, 2019 |
| Supracondylar Distal Femur Fractures and Abaloparatide NCT04626141 Daniel Horwitz | Withdrawn | Phase 4 | Jun 2024 |
| Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis NCT06154187 Pharmbio Korea Co., Ltd. | Unknown status | Phase 3 | Feb 2024 |
| PTH Analog Type II Odontoid Fracture NCT04760782 David Lunardini Results posted | Terminated | Phase 2 | May 18, 2022 |
Show 15 more studies
| Study | Status | Phase | Start |
| Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women NCT04974723 Radius Health, Inc. Results posted | Completed | — | July 1, 2021 |
| Effect of Abaloparatide on Lumbar Disc Degeneration NCT03708926 Johns Hopkins University | Withdrawn | Phase 2 | Mar 2021 |
| Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women. NCT04936984 Radius Health, Inc. | Completed | Phase 1 | November 16, 2020 |
| Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women. NCT04663464 Radius Health, Inc. | Completed | Phase 1 | November 16, 2020 |
| Abaloparatide and Pelvic Fracture Healing NCT04249232 Hospital for Special Surgery, New York | Completed | Phase 2 | September 17, 2020 |
| Abaloparatide Before Total Knee Arthroplasty NCT04167163 University of Wisconsin, Madison Results posted | Completed | Phase 4 | January 10, 2020 |
| Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis NCT04064411 Radius Health, Inc. Results posted | Completed | Phase 3 | August 5, 2019 |
| Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD) NCT04366726 Radius Health, Inc. Results posted | Completed | Phase 1 | April 9, 2019 |
| A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes NCT03746041 University of Rochester | Completed | Phase 1 | February 14, 2019 |
| Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption NCT03710889 Radius Health, Inc. Results posted | Completed | Phase 3 | September 20, 2018 |
| Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) NCT03512262 Radius Health, Inc. Results posted | Completed | Phase 3 | May 3, 2018 |
| Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis NCT01657162 Radius Health, Inc. Results posted | Completed | Phase 3 | November 20, 2012 |
| Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis NCT01674621 Radius Health, Inc. Results posted | Completed | Phase 2 | September 25, 2012 |
| Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women NCT01343004 Radius Health, Inc. Results posted | Completed | Phase 3 | Apr 2011 |
| Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis NCT00542425 Radius Health, Inc. Results posted | Completed | Phase 2 | Apr 2007 |
All 25 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 29,291
- Serious
- 4,970
- With death outcome
- 314
Most reported reactions
- Headache 5,125
- Nausea 3,915
- Dizziness 3,862
- Fatigue 3,423
- Product dose omission issue 2,654
- Heart rate increased 2,595
- Arthralgia 2,344
- Palpitations 2,225
- Bone pain 1,812
- Pain 1,566
- Back pain 1,539
- Injection site bruising 1,201
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Tymlos HUMAN PRESCRIPTION DRUG Radius Health, Inc. August 11, 2026
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.