Ulotaront
Small molecule targets HTR1A, TAAR1 via activation
Trials 27 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01940159 Comparator | Aug 2013 → Mar 2014 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Sumitomo Revise License Agreement- Otsuka holds exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 worldwide - otsuka.co.jp ↗ |
| 2023-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia otsuka.co.jp ↗ |
| 2023-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia otsuka-us.com ↗ |
| 2023-04-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder otsuka-us.com ↗ |
| 2022-12-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder otsuka-us.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 29 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 202328“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 |