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Drug

Abaloparatide

Approved medicine
ClassParathyroid hormone receptor agonistResearchOngoing clinical research

Also known as Tymlos.

RxNorm1921069ChEMBLCHEMBL3301581ATCH05AA04UNIIAVK0I6HY2U
3
Active clinical trials
PTH1R
Primary target
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Clinical trial2026-09-01Primary completion · ClinicalTrials.gov

Label change: ABALOPARATIDE (NDA208743)

Regulatory2026-08-03FDA

An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty

Clinical trial2026-06-05Results posted · ClinicalTrials.gov

The Effect of Osteoporotic Medications on Vertebral Bone Quality Score

Clinical trial2026-05-14Results expected Q2 2028 · ClinicalTrials.gov

Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Clinical trial2026-04-28Results expected Q1 2027 · ClinicalTrials.gov

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Clinical trial2025-06-01Withdrawn · ClinicalTrials.gov

Label change: ABALOPARATIDE (NDA208743)

Regulatory2025-03-28FDA

Effect of Abaloparatide on Lumbar Disc Degeneration

Clinical trial2024-02-01Withdrawn · ClinicalTrials.gov

Label change: ABALOPARATIDE (NDA208743)

Regulatory2023-12-21FDA

Effect of PTH Analog on Union Rates of Type II Odontoid Fractures in Older Adults

Clinical trial2023-08-14Terminated · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

Clinical trial2023-04-07Results posted · ClinicalTrials.gov

Indication expansion: ABALOPARATIDE (NDA208743)

Regulatory2022-12-19FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Abaloparatide
Aliases & brands
Tymlos
RxNorm CUI
1921069
ChEMBL ID
CHEMBL3301581
ATC codes
H05AA04
UNII
AVK0I6HY2U
Primary mechanism
Parathyroid hormone receptor agonist
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Parathyroid hormone/parathyroid hormone-related peptide receptor
PTH1R · Q03431
AGONISTParathyroid hormone receptor agonist

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2021-09-20 → 2022-12-19)
Earliest approval
2017-04-28
Latest approval
2022-12-19
Authorities
FDA · EMA
Total events
12
fdaU.S. Food and Drug Administration· 11 events
2026-08-03Label change
Label change: ABALOPARATIDE (NDA208743)
Evidence ↗
2025-03-28Label change
Label change: ABALOPARATIDE (NDA208743)
Evidence ↗
2023-12-21Label change
Label change: ABALOPARATIDE (NDA208743)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2022-12-12ApprovalMulti-authority
Approval: Eladynos (EMA)

Indication: Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
1
Recruiting
5
Late-stage (III+)
5
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 11
Phase 11Phase 25Phase 32Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Active, not recruitingPH IVHospital for Special Surgery, New Yorkn=702026

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

WithdrawnPH IVDaniel Horwitz2025

An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty

CompletedPH IVUniversity of Wisconsin, Madisonn=582025

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

CompletedPH IIIRadius Health, Inc.n=2282021

An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

CompletedPH IIIRadius Health, Inc.n=232020

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty

CompletedPH IVUniversity of Wisconsin, Madisonn=582025

A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes

CompletedPH IUniversity of Rochestern=202022

A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis

CompletedPH IIIRadius Health, Inc.n=2282021

An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

CompletedPH IIIRadius Health, Inc.n=232020

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis

CompletedPH IIRadius Health, Inc.n=2502013
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.