Drugs / Belvarafenib
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04835805 | May 2021 → Dec 2026 expected | melanoma | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07688356 | Jun 2026 → Jun 2028 expected | metastatic malignant neoplasm in the brain, primary brain neoplasm | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07449754 | Feb 2026 → Sep 2029 expected | melanoma | Hanmi Pharmaceutical Company Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Hanmi Pharmaceutical Company Limited | Results Hanmi R&D Aims to Close the Treatment Gap in Melanoma as Belvarafenib Advances Through Phase 2 Trial hanmipharm.com ↗
Meaningful antitumor efficacy demonstrated in patients with NRAS-mutant melanoma, for which no approved therapies exist in Korea or globally |
| 2026-01-08 | Hanmi Pharmaceutical Company Limited | Regulatory Hanmi to Advance Korea’s First Domestic Melanoma Therapy, Belvarafenib, Following Phase 2 Clearance hanmipharm.com ↗
Hanmi announced on January 8 that the Ministry of Food and Drug Safety (MFDS) has cleared the Phase 2 Investigational New Drug (IND) application for Belvarafenib, a targeted anticancer therapy. |
| 2026-01-08 | Hanmi Pharmaceutical Company Limited | Regulatory “치료제 없어 고통받는 환자 위한 한미의 길”… 흑색종 신약 2상 돌입 hanmi.co.kr ↗
한미사이언스 핵심 사업회사 한미약품은 지난 5일 식품의약품안전처로부터 표적 항암신약 ‘벨바라페닙(Belvarafenib)’에 대한 국내 임상 2상 시험계획서(IND)를 승인받았다고 8일 밝혔다. |
| 2023-11-06 | Hanmi Pharmaceutical Company Limited | Results 한미약품 “벨바라페닙, 치료제 없는 ‘BRAF 변이 고형암’ 타깃 가능성 확인” 한미약품 “벨바라페닙, 치료제 없는 ‘BRAF 변이 고형암’ 타깃 가능성 확인” hanmi.co.kr ↗
분석 결과에 따르면, 이 서브 코호트의 객관적 반응률(Overall Response Rate, ORR)은 67%(15명 중 10명), 질병 조절률(Disease Control Rate, DCR)은 93.3%, 반응지속시간(Duration of Response, DOR)의 중간값은 12개월, 무진행생존기간(Progression Free Survival, PFS)의 중간값은 13.7개월로 확인됐다. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Hanmi Pharmaceutical Company Limited | Hanmi R&D Aims to Close the Treatment Gap in Melanoma as Belvarafenib Advances Through Phase 2 Trial hanmipharm.com ↗ |
| 2026-02-19 | Hanmi Pharmaceutical Company Limited | Hanmi Begins Dosing in Phase 2 Trial of Belvarafenib, a Novel Melanoma Therapy hanmipharm.com ↗ |
| 2026-01-08 | Hanmi Pharmaceutical Company Limited | Hanmi to Advance Korea’s First Domestic Melanoma Therapy, Belvarafenib, Following Phase 2 Clearance hanmipharm.com ↗ |
| 2026-01-08 | Hanmi Pharmaceutical Company Limited | “치료제 없어 고통받는 환자 위한 한미의 길”… 흑색종 신약 2상 돌입 hanmi.co.kr ↗ |
| 2023-11-06 | Hanmi Pharmaceutical Company Limited | 한미약품 “벨바라페닙, 치료제 없는 ‘BRAF 변이 고형암’ 타깃 가능성 확인” 한미약품 “벨바라페닙, 치료제 없는 ‘BRAF 변이 고형암’ 타깃 가능성 확인” hanmi.co.kr ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belvarafenib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04589845 ↗ |
| Action | Inhibit | “Belvarafenib is an oral pan-RAF inhibitor” NCT07688356 ↗ |
| Modality | Small molecule | — CHEMBL3977543 ↗ |
| Route | Oral | “400 mg, PO, BID” NCT04589845 ↗ |