NBI-1117570 · program
NBI-1117570 for Schizophrenia
Schizophrenia is the lead indication for NBI-1117570 (NBI-570), an oral dual muscarinic M1/M4 agonist. A Phase 2a, multicenter, randomized, double-blind, placebo-controlled inpatient study (NCT07288333; org study id NBI-1117570-SCZ2035) is evaluating efficacy, safety, tolerability and pharmacokinetics in adults with schizophrenia who warrant inpatient hospitalization. The study has three arms (lower dose, higher dose, placebo) and is expected to enroll approximately 120 patients; the primary endpoint is change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Day 35. The study started 16 Feb 2026 and the first patient was dosed in April 2026 (announced 12-13 Apr 2026), which triggered a US$22.5 million milestone payment from Neurocrine to Nxera Pharma. NBI-1117570 was discovered by Nxera using its NxWave platform and is the second NxWave-designed muscarinic compound in Neurocrine's portfolio to reach Phase 2. Estimated primary completion is August 2027. As of mid-2026 the program is active and recruiting.
Development timeline
- UpcomingAnticipated topline from the Phase 2a inpatient schizophrenia study (PANSS total change at Day 35).
- First 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.↗
- Phase 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.
Readouts
- 2H 2027AnticipatedTopline dataNCT07288333
Anticipated topline from the Phase 2a inpatient schizophrenia study (PANSS total change at Day 35).
Clinical trials in Schizophrenia
NCT07288333NBI-1117570-SCZ2035Phase 2Recruitingn=120
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
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| NBI-1117570 oral Investigational oral formulation evaluated in Phase 1 (healthy adults) and Phase 2 (adults with schizophrenia); specific dose amounts not disclosed. | Oral | — | — |
Mechanism of action
Dual orthosteric agonist of the muscarinic acetylcholine M1 (CHRM1) and M4 (CHRM4) receptors. M4 is a Gi/o-coupled GPCR whose agonism in striatal/cortical circuits is hypothesized to dampen dopaminergic hyperactivity and produce antipsychotic effects via a non-D2 mechanism; M1 is a Gq-coupled GPCR implicated in cognition, and its activation is positioned to provide pro-cognitive benefit. The developer characterizes M1 as a clinically validated target for cognition and M4 for psychosis. Combining M1 and M4 agonism in a single molecule is intended to address both the psychotic and cognitive dimensions of schizophrenia. Quantitative binding/potency constants (Ki/EC50) for this exact molecule at M1 and M4 have not been publicly disclosed.
| Target | Action | Affinity |
|---|---|---|
| M4primaryCHRM4 | Agonist | —ⓘ |
| M1CHRM1 | Agonist | —ⓘ |
← Full NBI-1117570 compound page (identity, identifiers, all indications)
Sources
- Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia — ClinicalTrials.gov
- M1 receptor (CHRM1), GtoPdb object 13 — IUPHAR/BPS Guide to Pharmacology
- M4 receptor (CHRM4), GtoPdb object 16 — IUPHAR/BPS Guide to Pharmacology
- Nxera Pharma's Partner Neurocrine Biosciences Doses First Patient in Phase 2 Trial of NBI-1117570 for Adults with Schizophrenia — Nxera Pharma / GlobeNewswire
- Nxera Pharma's Partner Neurocrine Biosciences Doses First Patient in Phase 2 Trial of NBI-1117570 for Adults with Schizophrenia — BioSpace / Nxera Pharma press release