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Roluperidone FDA Approval Status

FDA Approved: No
Generic name: roluperidone
Company: Minerva Neurosciences, Inc.
Treatment for: Schizophrenia

Roluperidone is a 5-HT2A and sigma2 receptor antagonist in development for the treatment of certain symptoms in patients with schizophrenia.

Development timeline for roluperidone

DateArticle
Feb 27, 2024Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
May 10, 2023Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Dec 28, 2022Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Oct 17, 2022Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Aug 22, 2022Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
Nov 19, 2018Minerva Neurosciences Announces Results of Dose Escalation Study Evaluating Roluperidone (MIN-101) Administered at Supra-Therapeutic Doses in Healthy Volunteers

Further information

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