相关临床试验
9
9 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1988
进行中（未招募）
9
100.0%
暂无批准数据
- Medivir initiated FLEX-HCC, a randomized Phase 2 study of fostrox plus lenvatinib versus lenvatinib monotherapy in second-line advanced liver cancer, with the first patient enrolled in May 2026. - The Phase 1b/2a results for fostrox plus lenvatinib were published in Clinical Cancer Research, providing peer-reviewed confirmation of tumor-selective efficacy without impairing liver function. - A directed share issue of approximately SEK 140 million funds clinical development of MIV-711 in Perthes disease, expanding the candidate into a second rare bone indication alongside Osteogenesis Imperfecta. - Medivir received a Notice of Allowance from the USPTO for a combination patent covering fostrox plus lenvatinib, securing market exclusivity until at least April 2041.
- Medivir AB completed an oversubscribed directed share issue raising approximately SEK 130 million, with existing shareholders committing SEK 70 million. - Proceeds will primarily fund a proof-of-concept clinical trial for MIV-711 in Legg-Calvé-Perthes disease, a rare pediatric condition with no approved drug treatment. - MIV-711 has received both FDA Orphan Drug Designation and Rare Pediatric Disease Designation, potentially qualifying for a Priority Review Voucher upon approval. - Medivir estimates peak annual sales of approximately SEK 9.4 billion five years after launch in Europe and the U.S. for the Perthes disease indication.
- Phase 1b/2a study results for fostrox combined with lenvatinib in advanced hepatocellular carcinoma have been published in the peer-reviewed journal Clinical Cancer Research. - The liver-targeted prodrug demonstrated promising preliminary efficacy with a favorable safety profile in patients who had previously received immunotherapy. - Most patients (71%) required no dose modifications, and the combination achieved tumor control without deterioration of liver function. - An investigator-initiated randomized phase 2 study comparing fostrox plus lenvatinib versus lenvatinib monotherapy is currently ongoing in Korea.
- Medivir AB announced that the FDA has granted Orphan Drug Designation to MIV-711, a selective cathepsin K inhibitor, for treating osteogenesis imperfecta, a rare genetic bone disorder. - The designation provides significant regulatory benefits including tax credits, FDA fee exemptions, and seven years of marketing exclusivity for this rare disease affecting fewer than 200,000 Americans. - Preclinical studies in OI-specific animal models demonstrated that MIV-711 significantly improved bone strength, quality, and morphology in a dose-dependent manner. - Currently, there are no approved treatment options for patients diagnosed with osteogenesis imperfecta, representing a significant unmet medical need in this patient population.
- Medivir AB has granted exclusive global licensing rights for remetinostat, a topical HDAC inhibitor in phase 2 clinical trials, to AI-native drug developer Biossil Inc. - The compound has demonstrated positive clinical data in basal cell carcinoma and cutaneous T-cell lymphoma, addressing urgent unmet medical needs in cancer treatment. - Under the agreement terms, Medivir could receive up to $60 million in milestone payments plus mid-single digit royalties on future net sales if the drug reaches commercialization. - Biossil plans to resume development using its proprietary AI-driven approach, focusing on the drug's differentiated mechanism of action and clinical potential.
