Developer · NBIX · United States
Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a San Diego-based, NASDAQ-listed neuroscience biopharmaceutical company developing and commercializing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a CNS pipeline spanning schizophrenia, depression, and other psychiatric conditions.
Phase distribution
Modality
- Small molecule 6
Mechanism focus
- M4 2
- AMPA receptor (GluA1) 1
- DAAO 1
- GluN2B 1
- VMAT2 1
Pipeline (6)
- SchizophreniaPhase 3Active
- Bipolar disorderPhase 2Recruiting
- Major depressive disorderPhase 3Recruiting
- Tardive DyskinesiaPhase 2Recruiting
- Major depressive disorderPhase 2Completed
- SchizophreniaPhase 2Recruiting
- SchizophreniaDiscontinuedDiscontinued
Deals & partnerships
- Direclidine (NBI-1117568)Licensor Nxera Pharma Co., Ltd.
- Luvadaxistat (TAK-831)Licensor Takeda Pharmaceutical Company Limited
- NBI-1070770Licensor Takeda Pharmaceutical Company Limited
- NBI-1117570Licensor Nxera Pharma Co., Ltd.
- Osavampator (NBI-1065845)Licensor Takeda Pharmaceutical Company LimitedPartner Takeda Pharmaceutical Company Limited
- Jan 27, 2025PartnershipNeurocrine–Takeda amend collaboration for osavampator (ex-Japan vs. Japan split)On 27 Jan 2025 the collaboration was amended so Neurocrine holds exclusive worldwide rights (except Japan) to osavampator, while Takeda reacquires exclusive rights in Japan.
- Nov 22, 2021Licensing dealNBI-1117570 in-licensed under the Neurocrine–Sosei Heptares (Nxera) muscarinic collaborationNBI-1117570 (NBI-570), an oral M1/M4 selective dual agonist, is the second clinical candidate from the muscarinic portfolio licensed from Sosei Heptares (now Nxera Pharma) under the November 2021 agreement.
- Nov 22, 2021Licensing dealNeurocrine in-licenses Sosei Heptares (Nxera) muscarinic agonist portfolioStrategic collaboration and license to a portfolio of subtype-selective M1/M4 muscarinic agonists discovered by Sosei Heptares (now Nxera Pharma): ~$100M upfront and up to ~$2.6B milestones plus tiered royalties. NBI-1117568 (oral selective M4 agonist for schizophrenia) is the lead asset.
- Jun 12, 2020Licensing dealNeurocrine in-licenses osavampator (NBI-1065845 / TAK-653) from TakedaOsavampator (NBI-1065845, formerly TAK-653), an AMPA receptor positive allosteric modulator for MDD, originated at Takeda and was in-licensed under the 12 Jun 2020 exclusive license to seven Takeda psychiatry programs.
- Jun 12, 2020Licensing dealNeurocrine in-licenses luvadaxistat (TAK-831) from TakedaUnder a 12 Jun 2020 exclusive license, Takeda granted Neurocrine rights to seven early/mid-stage psychiatry programs (up to ~$2B). Luvadaxistat (NBI-1065844 / TAK-831), a DAAO inhibitor, was among them.
- Jun 12, 2020Licensing dealNBI-1070770 in-licensed from Takeda (2020 psychiatry portfolio deal)NBI-1070770, studied in MDD, originated at Takeda and was among the seven psychiatry programs exclusively licensed to Neurocrine under the 12 Jun 2020 agreement.
Catalysts · 5 upcoming · 3 reported
- 1H 2027Anticipated
NBI-1065890forTardive DyskinesiaTopline data
Phase 2 NBI-1065890 vs placebo topline in tardive dyskinesia (primary endpoint: change from baseline in AIMS dyskinesia total score at Week 8)
- 2H 2027Anticipated
NBI-1117570forSchizophreniaTopline data
Anticipated topline from the Phase 2a inpatient schizophrenia study (PANSS total change at Day 35).
- Q4 2027Anticipated
Direclidine (NBI-1117568)forSchizophreniaTopline data
Anticipated topline from Phase 3 acute study SCZ3029 (PANSS at Week 6).
- Q4 2027Anticipated
Direclidine (NBI-1117568)forSchizophreniaTopline data
Anticipated topline from Phase 3 acute study SCZ3030 (PANSS at Week 6).
- 1H 2028Anticipated
Direclidine (NBI-1117568)forBipolar disorderTopline data
Anticipated topline from the Phase 2 bipolar I mania study (NBI-1117568-BPD2036): change from baseline in YMRS total score at Day 21.
Recently reported
- 2024-09-12missed
Luvadaxistat (TAK-831)forSchizophreniaTopline data
ERUDITE Phase 2 missed its primary BACS cognition endpoint; Neurocrine discontinued luvadaxistat.
- 2024-08-28met
Direclidine (NBI-1117568)forSchizophreniaTopline data
Phase 2 met its primary endpoint: 20 mg QD gave placebo-adjusted PANSS -7.5 at Week 6 (p=0.011, ES 0.61).
- 2021-03-02mixed
Luvadaxistat (TAK-831)forSchizophreniaTopline data
INTERACT missed its primary negative-symptom endpoint (PANSS NSFS) but hit cognitive secondaries (BACS, SCoRS) at 50 mg.
Recent activity
- Apr 12, 2026Phase changeNBI-1117570·SchizophreniaPhase 2First patient DOSED in the Phase 2 trial of NBI-1117570 for adults with schizophrenia (announced 12-13 Apr 2026); milestone payment of US$22.5M to Nxera Pharma on Phase 2 initiation. Described as Nxera-discovered (NxWave platform), the second such compound in Neurocrine's muscarinic portfolio to reach Phase 2.source ↗
- Feb 16, 2026Phase changeNBI-1117570·SchizophreniaPhase 2Phase 2a inpatient schizophrenia study NCT07288333 (NBI-1117570-SCZ2035) started (actual study start date per ClinicalTrials.gov); randomized, double-blind, placebo-controlled; ~120 patients; primary endpoint PANSS total change at Day 35.source ↗
- Feb 6, 2026Phase changeNBI-1065890·Tardive DyskinesiaPhase 2Phase 2 study in adults with tardive dyskinesia initiated (announced 2026-01-26; ClinicalTrials.gov study start date 2026-02-06).source ↗
- Dec 24, 2025Phase changeDireclidine (NBI-1117568)·Bipolar disorderPhase 2Phase 2 bipolar I mania study (NCT07288320 / NBI-1117568-BPD2036, n~150) started (actual start date 2025-12-24 per ClinicalTrials.gov); status RECRUITING. Primary endpoint: change from baseline in YMRS total score at Day 21; estimated primary completion Feb 2028.source ↗
- Nov 10, 2025Phase changeNBI-1070770·Major depressive disorderPhase 2Phase 2 MDD study did NOT meet the primary endpoint vs placebo; generally well tolerated; next steps under analysis.source ↗
- Apr 30, 2025Phase changeDireclidine (NBI-1117568)·SchizophreniaPhase 3Phase 3 registrational program initiated (acute studies SCZ3029/SCZ3030, long-term SCZ3032, relapse-prevention) following positive Phase 2 data.source ↗
- Jan 22, 2025Phase changeOsavampator (NBI-1065845)·Major depressive disorderPhase 3Phase 3 registrational program initiated (adjunctive MDD; five studies, three pivotal).source ↗
- Jan 14, 2025Phase changeDireclidine (NBI-1117568)·Bipolar disorderPhase 2Neurocrine guided (via partner Nxera Pharma portfolio update) that it expected to initiate a Phase 2 study of NBI-1117568 ('NBI-'568') in bipolar mania in 2H 2025.source ↗
- Sep 12, 2024ReadoutLuvadaxistat (TAK-831)·SchizophreniamissedERUDITE Phase 2 missed its primary BACS cognition endpoint; Neurocrine discontinued luvadaxistat.source ↗
- Aug 28, 2024ReadoutDireclidine (NBI-1117568)·SchizophreniametPhase 2 met its primary endpoint: 20 mg QD gave placebo-adjusted PANSS -7.5 at Week 6 (p=0.011, ES 0.61).source ↗
- Apr 23, 2024Phase changeOsavampator (NBI-1065845)·Major depressive disorderPhase 2Positive Phase 2 SAVITRI topline; primary + secondary endpoints met at 1 mg.source ↗
- Apr 8, 2024Phase changeNBI-1070770·Major depressive disorderPhase 2First patient dosed in Phase 2 MDD study (NCT06267846).source ↗
Trials recruiting · 14 recruiting of 53 sponsored
- Phase 4Valbenazine
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
- Phase 3Direclidine (NBI-1117568)
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
- Phase 3NBI-1065845, Placebo
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
- Phase 3Direclidine (NBI-1117568)
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
- Phase 3Direclidine (NBI-1117568)
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
- Phase 3NBI-1065845, Placebo
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
- Phase 3Direclidine (NBI-1117568)
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
- Phase 3NBI-1065845
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
- Phase 3Osavampator (NBI-1065845)
NBI-1065845 as Adjunctive Treatment in Major Depressive Disorder (Phase 3)
- Phase 3Osavampator (NBI-1065845)
NBI-1065845 as Adjunctive Treatment in Major Depressive Disorder (Phase 3)
- Phase 3Valbenazine
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
- Phase 2NBI-1117570
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
- Phase 2Direclidine (NBI-1117568)
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Showing 13 of 14 recruiting trials.
Competitive landscape
Other companies developing against Neurocrine Biosciences, Inc.'s targets or indications.
- Boehringer Ingelheim International GmbH3 compoundsGluN2BSchizophreniaMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.2 compoundsM4SchizophreniaMajor depressive disorder
- Intra-Cellular Therapies, Inc.1 compoundSchizophreniaBipolar disorderMajor depressive disorder
- Vanda Pharmaceuticals Inc.2 compoundsSchizophreniaBipolar disorderMajor depressive disorder
- Alto Neuroscience, Inc.3 compoundsSchizophreniaMajor depressive disorder
- Biohaven Ltd.1 compoundBipolar disorderMajor depressive disorder
- LB Pharmaceuticals Inc.1 compoundSchizophreniaMajor depressive disorder
- Syndeio Biosciences, Inc.2 compoundsGluN2BMajor depressive disorder
- Alkermes plc1 compoundSchizophrenia
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Axsome Therapeutics, Inc.1 compoundMajor depressive disorder
- Beckley Psytech Limited1 compoundMajor depressive disorder
