abiraterone
abiraterone: developed by 1 company · 69 clinical trials tracked · 1 FDA decision.
abiraterone evidence translation
What we can confirm
1 FDA record · 69 tracked trials
What it means
What to watch
Prepared research question
How could abiraterone → RDY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 17 study sponsors
Related indications
Development Pipeline (2)
| Company | Phase |
|---|---|
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (69)showing 10 most recent
A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
Primary endpoint: Radiographic progression-free survival (rPFS)
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Primary endpoint: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer
Primary endpoint: Incidence and severity of dose-limiting toxicities (DLTs)
A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
Primary endpoint: Radiographic Progression-Free Survival (rPFS)
A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer
Primary endpoint: Radiographic Progression-free Survival (rPFS)
TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer
Primary endpoint: Phase I (Group A and Group B): Dose-limiting toxicities (DLTs)
A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)
Primary endpoint: Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs)
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Primary endpoint: OS
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Primary endpoint: Number of Participants with Treatment-emergent Adverse Events
An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
Primary endpoint: Maximum tolerated dose (MTD) (Phase Ib)
FDA Decisions1 records
Frequently asked questions
Who is developing abiraterone?
abiraterone is being developed by DR REDDYS LABORATORIES LTD.
How many clinical trials involve abiraterone?
BioSniper tracks 69 clinical trials involving abiraterone.
What is abiraterone's latest FDA decision?
The most recent tracked FDA decision for abiraterone is Approval for 1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1) metastatic high-risk castration-sensitive prostate cancer (CSPC, dated May 18, 2020.