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Abiraterone + Prednisolone/Prednisone
Abiraterone + Prednisolone/Prednisone is a CYP17A1 inhibitor (androgen synthesis inhibitor) + glucocorticoid Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC), High-risk metastatic hormone-sensitive prostate cancer (mHSPC).
Abiraterone inhibits CYP17A1 to block androgen synthesis, while prednisolone/prednisone suppresses ACTH-driven adrenal compensation and provides anti-inflammatory effects.
Abiraterone inhibits CYP17A1 to block androgen synthesis, while prednisolone/prednisone suppresses ACTH-driven adrenal compensation and provides anti-inflammatory effects. Used for Metastatic castration-resistant prostate cancer (mCRPC), High-risk metastatic hormone-sensitive prostate cancer (mHSPC).
At a glance
| Generic name | Abiraterone + Prednisolone/Prednisone |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | CYP17A1 inhibitor (androgen synthesis inhibitor) + glucocorticoid |
| Target | CYP17A1 (17α-hydroxylase/17,20-lyase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Abiraterone acetate is a selective inhibitor of 17α-hydroxylase/17,20-lyase (CYP17A1), a key enzyme in androgen biosynthesis in the testes and adrenal glands. By blocking this enzyme, abiraterone reduces circulating testosterone and other androgens, which are critical for castration-resistant prostate cancer (CRPC) cell growth. Prednisolone or prednisone is co-administered to suppress compensatory ACTH-driven adrenal androgen production and to mitigate mineralocorticoid excess caused by shunting of steroid precursors.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC)
- High-risk metastatic hormone-sensitive prostate cancer (mHSPC)
Common side effects
- Hypertension
- Hypokalemia
- Fluid retention/edema
- Fatigue
- Joint pain/arthralgia
- Diarrhea
- Urinary tract infection
- Elevated liver enzymes
- Cardiovascular events
Key clinical trials
- M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (PHASE1)
- Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) (PHASE3)
- A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation (PHASE3)
- A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer (PHASE2)
- RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer) (PHASE4)
- The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only (PHASE3)
- Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PHASE3)
- A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Abiraterone + Prednisolone/Prednisone CI brief — competitive landscape report
- Abiraterone + Prednisolone/Prednisone updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Abiraterone + Prednisolone/Prednisone
What is Abiraterone + Prednisolone/Prednisone?
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What is Abiraterone + Prednisolone/Prednisone used for?
Who makes Abiraterone + Prednisolone/Prednisone?
What drug class is Abiraterone + Prednisolone/Prednisone in?
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What does Abiraterone + Prednisolone/Prednisone target?
Related
- Drug class: All CYP17A1 inhibitor (androgen synthesis inhibitor) + glucocorticoid drugs
- Target: All drugs targeting CYP17A1 (17α-hydroxylase/17,20-lyase)
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC)
- Indication: Drugs for High-risk metastatic hormone-sensitive prostate cancer (mHSPC)
- Compare: Abiraterone + Prednisolone/Prednisone vs similar drugs
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