NBI-1065890 · program

NBI-1065890 for Tardive Dyskinesia

Phase 2RecruitingNeurocrine Biosciences, Inc. (NBIX)

Phase 2, randomized, double-blind, placebo-controlled study (NCT07365462 / NBI-1065890-TD2033) evaluating efficacy, safety, and tolerability of NBI-1065890 versus placebo over 8 weeks in ~100 adults (18-75) with moderate-to-severe tardive dyskinesia and an underlying psychiatric condition. Primary endpoint: change from baseline in AIMS dyskinesia total score at Week 8. Trial initiation announced 2026-01-26.

Data current as of

Development timeline

Phase 2Feb 2026 – Feb 2027
  1. UpcomingPhase 2 NBI-1065890 vs placebo topline in tardive dyskinesia (primary endpoint: change from baseline in AIMS dyskinesia total score at Week 8)
  2. Phase 2 study in adults with tardive dyskinesia initiated (announced 2026-01-26; ClinicalTrials.gov study start date 2026-02-06).↗
Phase 1Mar 2024
  1. Neurocrine announced initiation of a Phase 1 first-in-human clinical study evaluating safety, tolerability, PK and PD of NBI-1065890 (described as a second-generation/next-generation selective VMAT2 inhibitor) in healthy adults.↗

Readouts

  • 1H 2027AnticipatedTopline dataNCT07365462

    Phase 2 NBI-1065890 vs placebo topline in tardive dyskinesia (primary endpoint: change from baseline in AIMS dyskinesia total score at Week 8)

Clinical trials in Tardive Dyskinesia

NCT07365462NBI-1065890-TD2033Phase 2Recruitingn=100

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia

Started Feb 2026· Primary completion Feb 2027

Formulations

FormulationRouteRegimenPharmacokinetics
NBI-1065890 oralOral——

Mechanism of action (compound-wide)

Selective inhibitor of vesicular monoamine transporter 2 (VMAT2, SLC18A2). VMAT2 sequesters cytosolic monoamines (notably dopamine) into presynaptic vesicles; inhibiting it reduces dopamine packaging/release and dampens the dopaminergic hyperactivity implicated in tardive dyskinesia, the same mechanistic class as valbenazine, deutetrabenazine, and tetrabenazine.

TargetActionAffinity
VMAT2primarySLC18A2Inhibitor—ⓘ

← Full NBI-1065890 compound page (identity, identifiers, all indications)

Sources

  1. Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia (NCT07365462; NBI-1065890-TD2033) — ClinicalTrials.gov
  2. Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia (NCT07365462) — ClinicalTrials.gov
  3. Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1065890, a Second-Generation VMAT2 Inhibitor, in Healthy Adults — Neurocrine Biosciences
  4. Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1065890 in Adults with Tardive Dyskinesia — Neurocrine Biosciences / PR Newswire
  5. Vesicular monoamine transporter 2 (SLC18A2) | SLC18 family of vesicular amine transporters — IUPHAR/BPS Guide to PHARMACOLOGY