PTHrP analogue

Abaloparatide updates

Answer

4 changes for Abaloparatide in the last 12 months. Latest: 2026-08-11.

DateTypeWhat changedSource
2026-08-11LabelFDA label revised: Tymlos (NDA208743)Regulator FDA drug label register
2026-06-05ResultsResults posted: Abaloparatide Before Total Knee ArthroplastyTrial register ClinicalTrials.gov
2026-06-01TrialNew trial registered: MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal OsteoporosisTrial register ClinicalTrials.gov
2026-05-14TrialNew trial registered: The Effect of Osteoporotic Medications on Vertebral Bone Quality ScoreTrial register ClinicalTrials.gov
2025-03-27TrialNew trial registered: To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High RiskTrial register ClinicalTrials.gov
2024-12-23TrialNew trial registered: A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide InjectiTrial register ClinicalTrials.gov
2024-09-19ResultsResults posted: PTH Analog Type II Odontoid FractureTrial register ClinicalTrials.gov
2024-04-19ResultsResults posted: Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal WomenTrial register ClinicalTrials.gov
2023-12-11TrialNew trial registered: Sequential Therapies After Osteoanabolic TreatmentTrial register ClinicalTrials.gov
2023-11-22ResultsResults posted: Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in PostTrial register ClinicalTrials.gov
2023-11-20TrialNew trial registered: Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2023-04-07ResultsResults posted: Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)Trial register ClinicalTrials.gov
2023-02-15ResultsResults posted: Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2021-10-15ResultsResults posted: Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and ResorptionTrial register ClinicalTrials.gov
2021-07-23TrialNew trial registered: Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal WomenTrial register ClinicalTrials.gov
2021-06-23TrialNew trial registered: Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.Trial register ClinicalTrials.gov
2021-02-18TrialNew trial registered: PTH Analog Type II Odontoid FractureTrial register ClinicalTrials.gov
2020-12-11ResultsResults posted: Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With OsteoporosisTrial register ClinicalTrials.gov
2020-12-11TrialNew trial registered: Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.Trial register ClinicalTrials.gov
2020-11-12TrialNew trial registered: Supracondylar Distal Femur Fractures and AbaloparatideTrial register ClinicalTrials.gov
2020-07-13TrialNew trial registered: Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab AloneTrial register ClinicalTrials.gov
2020-04-29TrialNew trial registered: Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) iTrial register ClinicalTrials.gov
2020-01-30TrialNew trial registered: Abaloparatide and Pelvic Fracture HealingTrial register ClinicalTrials.gov
2019-11-18TrialNew trial registered: Abaloparatide Before Total Knee ArthroplastyTrial register ClinicalTrials.gov
2019-08-21TrialNew trial registered: Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2019-02-15TrialNew trial registered: Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion SurgeryTrial register ClinicalTrials.gov
2018-11-19TrialNew trial registered: A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic SyndromesTrial register ClinicalTrials.gov
2018-10-22Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOSRegulator Federal Register
2018-10-18TrialNew trial registered: Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and ResorptionTrial register ClinicalTrials.gov
2018-10-17TrialNew trial registered: Effect of Abaloparatide on Lumbar Disc DegenerationTrial register ClinicalTrials.gov
2018-04-30TrialNew trial registered: Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)Trial register ClinicalTrials.gov
2017-03-01ResultsResults posted: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal WomenTrial register ClinicalTrials.gov
2016-12-19ResultsResults posted: Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2012-08-29TrialNew trial registered: Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2012-08-06TrialNew trial registered: Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With OsteoporosisTrial register ClinicalTrials.gov
2011-04-27TrialNew trial registered: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal WomenTrial register ClinicalTrials.gov
2010-07-29ResultsResults posted: Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov
2007-10-11TrialNew trial registered: Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With OsteoporosisTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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