Neurocrine Biosciences Reports Positive Phase 2 Results for Osavampator in Major Depressive Disorder

Neurocrine Biosciences announced positive Phase 2 results from the SAVITRI study for osavampator (NBI-1065845), a novel selective positive allosteric modulator of the AMPA receptor (AMPA-PAM), being developed for adults with major depressive disorder (MDD)124.

The study enrolled 183 adults and tested two doses (1 mg and 3 mg) versus placebo. The 1 mg dose achieved statistically significant improvements in depression severity at both Day 28 and Day 56, as measured by reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS)12.

The 1 mg dose of osavampator demonstrated superior response and remission rates compared to placebo. The 3 mg dose showed a trend towards improvement but did not reach statistical significance2.

Osavampator was well-tolerated, with no serious adverse events reported; the most common side effects were headache and nasopharyngitis, at rates similar to placebo12.

Neurocrine’s therapy represents a new mechanism distinct from existing antidepressants, many of which target monoamine systems; AMPA-PAMs act via glutamatergic pathways14.

These results have prompted Neurocrine to launch a Phase 3 registrational program for osavampator, with five ongoing studies as of January 202534.

Detailed new data are being presented at the 38th Annual Psych Congress 2025, where Neurocrine will discuss latest discoveries and trends in treating treatment-resistant depression34.

Sources:

1. https://www.stocktitan.net/news/NBIX/neurocrine-biosciences-presents-positive-new-data-from-phase-2-study-slaqfjbrkmir.html

2. https://www.biopharmadive.com/news/neurocrine-depression-study-medicine-takeda-results/714001/

3. https://www.towardshealthcare.com/news/neurocrine-osavampator-phase-2-savitri-psych-congress-2025

4. https://www.stocktitan.net/news/NBIX/neurocrine-biosciences-to-present-new-data-from-phase-2-study-of-eb58xuuacf9z.html