NBI-1065845 · program

Osavampator (NBI-1065845) for Major depressive disorder

Phase 3RecruitingNeurocrine Biosciences, Inc. (NBIX)

Adjunctive treatment for adults with MDD and inadequate response to ≥1 antidepressant. Phase 2 SAVITRI (NCT05203341) met its primary endpoint (1 mg). Phase 3 registrational program (five studies, three pivotal) initiated January 2025.

Data current as of

Development timeline

Phase 3Jan 2025
  1. Phase 3 registrational program initiated (adjunctive MDD; five studies, three pivotal).↗
Phase 2Apr 2024
  1. Positive Phase 2 SAVITRI topline; primary + secondary endpoints met at 1 mg.↗

Clinical trials in Major depressive disorder

NCT07196501Phase 3Recruitingn=550

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Started Aug 2025· Primary completion Jul 2028· 📍 45 sites across 11 countries (United States, Taiwan, Bulgaria, South Korea)

NCT06963021Phase 3Recruitingn=200

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Started May 2025· Primary completion Jul 2027· 📍 34 sites across 7 countries (United States, Hungary, United Kingdom, Belgium)

NCT06966401Phase 3Recruitingn=850

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Started Apr 2025· Primary completion May 2029· 📍 98 sites across 17 countries (United States, Poland, Bulgaria, Slovakia)

NCT06911112NBI-1065845-MDD3025Phase 3Recruitingn=200

NBI-1065845 as Adjunctive Treatment in Major Depressive Disorder (Phase 3)

Started Mar 2025· Primary completion Jul 2027· 📍 10 sites across 1 country (United States)

NCT06786624Phase 3Recruitingn=200

NBI-1065845 as Adjunctive Treatment in Major Depressive Disorder (Phase 3)

Started Jan 2025· Primary completion Jul 2027· 📍 18 sites across 1 country (United States)

NCT05203341SAVITRIPhase 2Completedn=183

Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (SAVITRI)

Started Feb 2022· Primary completion Jan 2024· 📍 41 sites across 6 countries (United States, Bulgaria, Czechia, Sweden)

metprimaryMADRS change at Day 28 (1 mg vs placebo) — -4.3 points (0.0159)

1 mg dose met the primary endpoint; effect deepened to -7.5 at Day 56 (p=0.0016).

Formulations

FormulationRouteRegimenPharmacokinetics
Osavampator oral
1 mg or 3 mg once daily (Phase 2 SAVITRI); Phase 1 single doses 0.3-18 mg
OralOnce dailyt½ 40.2 h · Tmax 5 h

Mechanism of action (compound-wide)

Selective AMPA-receptor positive allosteric modulator; potentiates glutamate-evoked AMPA currents by slowing desensitization, glutamate-dependently with minimal intrinsic agonism.

TargetActionAffinity
AMPA receptor (GluA1)primaryGRIA1PAMEC50 2.2 µMⓘ

← Full NBI-1065845 compound page (identity, identifiers, all indications)

Sources

  1. Agonist-dependent activation of AMPA-R by TAK-653 — Neuropsychopharmacology (PMC)
  2. clinicaltrials.gov — ClinicalTrials.gov
  3. clinicaltrials.gov — ClinicalTrials.gov
  4. clinicaltrials.gov — clinicaltrials.gov
  5. clinicaltrials.gov — clinicaltrials.gov
  6. clinicaltrials.gov — clinicaltrials.gov
  7. Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder — Neurocrine Biosciences
  8. Phase 3 registrational program for osavampator — Neurocrine / PR Newswire
  9. Positive Phase 2 data for NBI-1065845 in MDD — Neurocrine / PR Newswire
  10. SAVITRI (NCT05203341) — ClinicalTrials.gov