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Enzalutamide Soft Capsules
Enzalutamide Soft Capsules is a Androgen receptor antagonist Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer (mCRPC), Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic castration-sensitive prostate cancer (mCSPC).
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven gene transcription in prostate cancer cells.
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, preventing androgen-driven gene transcription in prostate cancer cells. Used for Metastatic castration-resistant prostate cancer (mCRPC), Non-metastatic castration-resistant prostate cancer (nmCRPC), Metastatic castration-sensitive prostate cancer (mCSPC).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Enzalutamide Soft Capsules |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Enzalutamide competitively inhibits androgen receptor (AR) signaling by blocking ligand binding, preventing AR nuclear localization, and inhibiting AR-mediated transcription. This mechanism suppresses the growth of androgen-dependent prostate cancer cells. The drug is effective in both castration-sensitive and castration-resistant prostate cancer settings.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Common side effects
- Fatigue
- Diarrhea
- Hot flashes
- Musculoskeletal pain
- Headache
- Hypertension
- Seizures
Key clinical trials
- An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (PHASE2)
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (PHASE3)
- A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer (PHASE3)
- Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer (PHASE2)
- Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression (PHASE2)
- A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). (PHASE3)
- Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer (PHASE2)
- A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer (PHASE4)
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:
- Enzalutamide Soft Capsules CI brief — competitive landscape report
- Enzalutamide Soft Capsules updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about Enzalutamide Soft Capsules
What is Enzalutamide Soft Capsules?
How does Enzalutamide Soft Capsules work?
What is Enzalutamide Soft Capsules used for?
Who makes Enzalutamide Soft Capsules?
What drug class is Enzalutamide Soft Capsules in?
What development phase is Enzalutamide Soft Capsules in?
What are the side effects of Enzalutamide Soft Capsules?
What does Enzalutamide Soft Capsules target?
Related
- Drug class: All Androgen receptor antagonist drugs
- Target: All drugs targeting Androgen receptor (AR)
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer (mCRPC)
- Indication: Drugs for Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Indication: Drugs for Metastatic castration-sensitive prostate cancer (mCSPC)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing