Drug Type Small molecule drug |
Synonyms SHR-3680, 艾瑞恩 |
Target |
Mechanism AR antagonists(Androgen Receptor antagonists) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date CN (28 Jun 2022), |
RegulationPriority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Special Review Project (CN) |
Molecular FormulaC22H20F3N3O4S |
InChIKeyKRBMOYIWQCZVHA-INIZCTEOSA-N |
CAS Registry1572045-62-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic castration-resistant prostate cancer | CN | 28 Jun 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Prostatic Cancer | Phase 3 | - | 18 May 2022 | |
Locally Advanced Prostate Carcinoma | Phase 3 | CN | 01 Nov 2021 | |
Prostate Cancer, Hereditary, 7 | Phase 3 | CN | 01 Nov 2021 | |
Castration-Resistant Prostatic Cancer | Phase 3 | BG | 30 May 2018 | |
Castration-Resistant Prostatic Cancer | Phase 3 | CZ | 30 May 2018 | |
Castration-Resistant Prostatic Cancer | Phase 3 | PL | 30 May 2018 | |
Castration-sensitive prostate cancer | Phase 3 | CN | 30 May 2018 | |
Castration-sensitive prostate cancer | Phase 3 | BG | 30 May 2018 | |
Castration-sensitive prostate cancer | Phase 3 | CZ | 30 May 2018 | |
Castration-sensitive prostate cancer | Phase 3 | PL | 30 May 2018 |
Phase 2 | 36 | fbtnkebyjl(mhhenknfrj) = nemvfrnmcd bubihlcqno (tiknquandi ) View more | Positive | 24 May 2024 | |||
Rezvilutamide 240 mg plus Docetaxel | fbtnkebyjl(mhhenknfrj) = lzijaepqpc bubihlcqno (tiknquandi ) View more | ||||||
Phase 3 | 654 | Rezvilutamide + ADT (deep PSA decline) | - | Positive | 22 Oct 2023 | ||
Bicalutamide + ADT (deep PSA decline) | |||||||
Phase 3 | 654 | ADT+Rezvilutamide | fukxpudxvh(ycjcbmlfsp) = ajfmbsjwam zxvznnlqgh (ghncfncxrz, NR ~ NR) View more | Superior | 05 Sep 2022 | ||
ADT+Bicalutamide | fukxpudxvh(ycjcbmlfsp) = iktixlzkiw zxvznnlqgh (ghncfncxrz, 15.7 ~ NR) View more | ||||||
Phase 3 | 654 | nmbgaufuid(fpxtpjbwkw): HR = 0.58 (95% CI, 0.42 - 0.8), P-Value = 0.0009 View more | Positive | 02 Jun 2022 | |||
NCT02691975 (Pubmed) Manual | Phase 1/2 | 197 | lewupjaaql(weqtfprqed) = ebxoeoywyw veconrerje (dzsyipjhgp, 61.0 ~ 74.5) View more | Positive | 04 Mar 2022 | ||
Phase 1/2 | 197 | zfpjiklpjf(mszgamtzja) = Not reached mjxuavjxom (abpfyvkcog ) View more | Positive | 13 Feb 2020 |