Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 04 Mar 2026

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

23 Feb 2026 According to Reunion Neuroscience, Inc. media release, the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to luvesilocin (formerly RE104) for the treatment of postpartum depression (PPD). BTD for luvesilocin is supported by strong positive efficacy data from the RECONNECT Phase 2 clinical trial.
20 Jan 2026 Results presented at the American College of Neuropsychopharmacology (ACNP) Annual Meeting and the poster presentation, according to Reunion Neuroscience media release.
20 Jan 2026 Results presented in the Reunion Neuroscience Media Release.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com