Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates to treat central nervous system diseases. It develops Roluperidone for the treatment of negative symptoms in patients with schizophrenia and MIN-301 for the treatment of Parkinson’s disease. The company was founded by Rogerio Vivaldi Coelho and Goeffrey Robin Race on April 23, 2007 and is headquartered in Burlington, MA.
相关临床试验
19
12 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
2007
进行中（未招募）
12
63.2%
已完成
6
31.6%
招募中
1
5.3%
暂无批准数据
- The FDA has confirmed that Minerva Neurosciences must conduct an additional confirmatory clinical trial for roluperidone to address deficiencies cited in the Complete Response Letter received in February 2024. - The required 52-week study will evaluate roluperidone as monotherapy at 64 mg daily dose in schizophrenia patients with impairing negative symptoms, using PANSS Marder negative symptoms factor score as the primary endpoint. - Facing financial constraints with $15.3 million in cash and the requirement for costly confirmatory studies, Minerva has initiated a strategic alternatives review to maximize shareholder value.
- A comprehensive pipeline report reveals over 75 companies are developing innovative treatments for major depressive disorder, with several promising candidates advancing through Phase III trials. - Key emerging therapies include SAGE Therapeutics' SAGE-217 oral neuroactive steroid, Relmada Therapeutics' REL-1017 NMDAR channel blocker, and COMPASS Pathways' psilocybin-based COMP360. - The MDD therapeutics market was valued at $7.2 billion in 2023 across seven major markets, with significant growth expected through 2034 driven by novel mechanisms of action. - Several candidates have received FDA Fast Track designation, including REL-1017 and VistaGen's PH10 nasal spray, highlighting regulatory support for innovative depression treatments.
