Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension

Next Previous
Trial Profile

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 May 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Roluperidone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Minerva Neurosciences

Most Recent Events

  • 13 May 2025 According to a Minerva Neurosciences media release, interactions with the FDA continue with the goal of addressing questions raised in the Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia as first disclosed in the first quarter of 2024.
  • 27 Feb 2024 According to a Minerva Neurosciences media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Companys New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
  • 27 Feb 2024 According to a Minerva Neurosciences media release, In the CRL, the FDA cited the following clinical deficiencies: Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness. The NDA submission lacks data on concomitant antipsychotic administration.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top