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Osavampator

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Neurocrine Biosciences, Inc.|Trials Updated: Oct 22, 2026

Osavampator development status

Highest phase Phase 3
Registered trials 6 across 1 sponsor since Jan 2022

Osavampator target and mechanism

Molecular targetGRIA4, GRIA3, GRIA2, GRIA1
Target classPositive Allosteric Modulator
ModalitySmall molecule
ChEMBLCHEMBL4594403

Also known as NBI-1065845

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials6
Total Enrollment2,183

FDA Designations

No designations recorded

Osavampator clinical trials

Osavampator · 6 trials · 1 indication

Phase 3 5Phase 2 1
NCT07196501A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
RECRUITING550 Analytics
NCT06963021NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
RECRUITING200 Analytics
NCT06966401Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
RECRUITING850 Analytics
NCT06911112NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
RECRUITING200 Analytics
NCT06786624Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder
RECRUITING200 Analytics
PHASE3RECRUITING
A Study to Evaluate the Maintenance Effect of Osavampator as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT07196501550
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PHASE3RECRUITING
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT06963021200
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PHASE3RECRUITING
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT06966401850
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PHASE3RECRUITING
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT06911112200
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PHASE3RECRUITING
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
NCT06786624200
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Study Endpoints

Primary Endpoints

Time from Randomization to Relapse
From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Baseline, Day 56
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Baseline through Week 52
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
Baseline, Day 28

Secondary Endpoints

Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
Baseline, Day 56
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
Baseline, Days 7, 14, and 56
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-label Treatment Period: OsavampatorEXPERIMENTALParticipants will be treated with osavampator during the open-label treatment period.
Randomized Double-blind Maintenance Period: OsavampatorEXPERIMENTALParticipants will be randomized to receive osavampator during the randomized double-blind maintenance period.
Randomized Double-blind Maintenance Period: PlaceboEXPERIMENTALParticipants will be randomized to receive matching placebo during the randomized double-blind maintenance period.
NBI-1065845EXPERIMENTALNBI-1065845 administered orally once a day.
PlaceboPLACEBO_COMPARATORPlacebo identical in appearance to NBI-1065845 will be administered orally once a day.
NBI-1065845 Low DoseEXPERIMENTALParticipants will receive low-dose NBI-1065845 orally once a day.
NBI-1065845 High DoseEXPERIMENTALParticipants will receive high-dose NBI-1065845 orally once a day.

Interventions

NameTypeDescription
OsavampatorDRUGOral tablet
PlaceboDRUGOral tablet
NBI-1065845DRUGNBI-1065845 tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites61

Key Inclusion Criteria: * Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. * Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * Participant must have been taking oral antide...

Countries:United StatesAustraliaBulgariaCanadaEstoniaItalyPolandSerbiaSouth KoreaSpainTaiwanBelgiumFinlandHungaryLatviaUnited KingdomCroatiaCzechiaLithuaniaNetherlandsRomaniaSlovakiaSweden
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Competitive Landscape -Major Depressive Disorder 109 trials

Top 20 of 31 competitors

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1065845, Osavampator
COMPASS Pathways Plc Sponsored ADRCMPS4PHASE3COMP360
Johnson & JohnsonJNJ4PHASE3Esketamine, Seltorexant
AbbVie, Inc.ABBV2PHASE3Cariprazine, Icalcaprant
Eli Lilly and CompanyLLY2PHASE3Brenipatide
Xenon Pharmaceuticals Inc.XENE3PHASE3Azetukalner
Definium Therapeutics, Inc.DFTX2PHASE3DT120
Axsome Therapeutics, Inc.AXSM2PHASE3Solriamfetol, Dextromethorphan-Bupropion
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Vortioxetine
Cybin, Inc.HELP3PHASE3CYB003
Vanda Pharmaceuticals Inc.VNDA1PHASE3Milsaperidone
AtaiBeckley Inc.ATAI3PHASE2VLS-01, BPL-003
ACADIA Pharmaceuticals Inc.ACAD1PHASE2ACP-211
Supernus Pharmaceuticals, Inc.SUPN1PHASE2SPN-821
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-300
Lipocine IncLPCN1PHASE3LPCN 1154A
Bristol-Myers Squibb CompanyBMY1PHASE2BMS-986511
Seaport Therapeutics, Inc.SPTX2PHASE2SPT-300
Tonix Pharmaceuticals Holding Corp.TNXP1PHASE2TNX-102 SL (Tonmya)
NRX Pharmaceuticals, Inc.NRXP1PHASE2NRX-101
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Recent Changes (Last 90 Days)

MEDIUMOct 22, 2026NCT07196501lastUpdatePostDate: changed
MEDIUMOct 22, 2026NCT07196501lastUpdatePostDate: changed
LOWAug 11, 2026NCT06911112lastUpdatePostDate: changed
LOWAug 11, 2026NCT06963021lastUpdatePostDate: changed
LOWAug 11, 2026NCT06911112lastUpdatePostDate: changed
LOWAug 11, 2026NCT06963021lastUpdatePostDate: changed
LOWAug 11, 2026NCT06963021lastUpdatePostDate: changed

Other drugs targeting GRIA4

Topiramate coated GSK· PHASE1 topiramate JNJ· PHASE3 Topiramate liquid formulation;Topiramate Sprinkle formulation JNJ· PHASE1 MK-8777 MRK· PHASE2 Topiramate IR SUPN· PHASE1 Topiramate TEVA· PHASE1 Topiramate 2 x TEVA· PHASE1 Topiramate Sprinkle VTRS· PHASE1

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