Drugs / NBI-1117568
last change Dec 2025 re-read 3 minutes ago

NBI-1117568

also known as HTL0016878
Developed for
schizophrenia · bipolar I disorder · manic bipolar affective disorder
Investigated by
Neurocrine Biosciences · Nxera Pharma UK Limited · Allergan

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04935320 Jul → Oct 2021 — Nxera Pharma UK Limited Completed No outcome recorded
Phase 1 NCT04849286 Sep → Dec 2018 — Nxera Pharma UK Limited Completed No outcome recorded
Phase 1 NCT03244228 Aug 2017 → Sep 2019 — Nxera Pharma UK Limited Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT07288320 Dec 2025 → Feb 2028 expected bipolar I disorder, manic bipolar affective disorder Neurocrine Biosciences Recruiting No outcome recorded
Phase 2 NCT05545111 Oct 2022 → Jul 2024 schizophrenia Neurocrine Biosciences Completed Met primary
Phase 34 trials
Phase 3 NCT07227818 Dec 2025 → Jul 2029 expected schizophrenia Neurocrine Biosciences Recruiting No outcome recorded
Phase 3 NCT07105098 Aug 2025 → Nov 2027 expected schizophrenia Neurocrine Biosciences Recruiting No outcome recorded
Phase 3 NCT07114874 Jul 2025 → Dec 2031 expected schizophrenia Neurocrine Biosciences Recruiting No outcome recorded
Phase 3 NCT06963034 May 2025 → Oct 2027 expected schizophrenia Neurocrine Biosciences Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2025-05-29 Nxera Pharma UK Limited Results Nxera Pharma Notes Neurocrine Biosciences Presents New Positive Data from Phase 2 Study of NBI-1117568 in Adults with Schizophrenia at American Society of Clinical Psychopharmacology 2025 nxera.life ↗
Neurocrine Biosciences, Inc. announced that it had presented new positive data from the Phase 2 study of NBI -1117568 in adults with schizophrenia at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting in Scottsdale, Arizona.
2024-08-28 Nxera Pharma UK Limited Results Nxera Pharma Notes Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568 nxera.life ↗
NBI-1117568 (NBI-‘568) has delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia.
2024-08-28 Nxera Pharma UK Limited Results Other nxera.life ↗
NBI-1117568-SCZ2028 用量設定試験は、20mg 1日 1 回投与群で主要評価項目を達成しました。
2022-08-05 Nxera Pharma UK Limited Regulatory Sosei Heptares’ Oral, Selective M4 Receptor Agonist Advancing into Phase 2 Clinical Development under Multi-Program Collaboration with Neurocrine nxera.life ↗
2022-08-05 Nxera Pharma UK Limited Regulatory Other nxera.life ↗

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as NBI-1117568 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06963034 ↗
5

NCT07114874 ↗

NCT07105098 ↗

NCT07288320 ↗

NCT05545111 ↗

NCT07227818 ↗

Known as HTL0016878 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03244228 ↗
2

NCT04935320 ↗

NCT04849286 ↗

Route Oral “Oral solution” NCT03244228 ↗