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Drug

Abaloparatide

Approved · EMA
Late-stage development

Also known as Tymlos.

RxNorm1921069UNIIAVK0I6HY2U
3
Active clinical trials
1
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 trial2026-06-08Results expected Q3 2026 · ClinicalTrials.gov

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

Effect of Abaloparatide on Lumbar Disc Degeneration

Clinical trial2024-02-01Withdrawn · ClinicalTrials.gov

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

Approval: Eladynos (EMA)

Regulatory2022-12-12EMA

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

Clinical trial2022-06-06Completed · ClinicalTrials.gov

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

Clinical trial2021-10-15Results posted · ClinicalTrials.gov

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

Clinical trial2020-06-16Results posted · ClinicalTrials.gov

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
UNII
AVK0I6HY2U
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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.

Earliest approval
2022-12-12
Latest approval
2022-12-12
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-12-12Approval
Approval: Eladynos (EMA)

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

Evidence ↗

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
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.