Ulotaront
Small molecule targets HTR1A, TAAR1 via activation
Trials 29
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-07-31 | Sumitomo Pharma America, Inc. | Results Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia sumitomo-pharma.com ↗
did not meet their primary endpoint. |
| 2023-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia otsuka.co.jp ↗
In the DIAMOND 2 study, ulotaront 75 mg/day and 100 mg/day treatment groups did not demonstrate statistically significant improvement compared to placebo on the primary endpoint. |
| 2023-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia otsuka-us.com ↗
In the DIAMOND 2 study, ulotaront 75 mg/day and 100 mg/day treatment groups did not demonstrate statistically significant improvement compared to placebo on the primary endpoint. |
All press releases naming this drug 7 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ulotaront | “Ulotaront, a trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptor agonist without antagonist activity at dopamine D2 or the serotonin 5-HT2A receptors, has...” PMID 37550314 ↗ Aug 20233“Ulotaront (SEP-363856) is a trace amine-associated receptor 1 agonist with 5-HT1A receptor agonist activity currently in phase 3 clinical development for the treatment of schizophrenia.” PMID 37273942 ↗ May 2023 “Ulotaront (SEP-363856) is a novel agonist at trace amine-associated receptor 1 and serotonin 5-HT1A receptors in clinical development for the treatment of schizophrenia.” PMID 37209427 ↗ Apr 2023 “Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia” NCT06894212 ↗ |
| Known as | SEP 363856 | “Ulotaront (SEP-363856) is a trace amine-associated receptor 1 agonist with 5-HT1A receptor agonist activity currently in phase 3 clinical development for the treatment of schizophrenia.” PMID 37273942 ↗ May 202330“Ulotaront (SEP-363856) is a novel agonist at trace amine-associated receptor 1 and serotonin 5-HT1A receptors in clinical development for the treatment of schizophrenia.” PMID 37209427 ↗ Apr 2023 “SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule” NCT04115319 ↗ “An oral 25 or 50mg dose of SEP 363856” NCT03370640 ↗ |
| Known as | SEP-363856 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650337 ↗ |
| Known as | SEP-363856-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650337 ↗ |
| Known as | SEP-856 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650337 ↗ |
| Known as | ULOTARONT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650337 ↗ |
| Action | Activate | “Ulotaront, a trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptor agonist without antagonist activity at dopamine D2 or the serotonin 5-HT2A receptors, has...” PMID 37550314 ↗ Aug 20231“Serotonin 1a (5-HT1a) receptor agonist” CHEMBL4650337 ↗ |
| Modality | Small molecule | — CHEMBL4650337 ↗ |
| Route | Oral | “single oral dose” NCT01940159 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL4650337 ↗ |
| Target | TAAR1 | “a TAAR1/5-HT1A agonist with antipsychotic-like activity” PMID 37273942 ↗ May 2023 |