lumateperone
Trade name: Caplyta
Approved
Dec 20, 2019
Lumateperone, sold under the brand name Caplyta, is an atypical antipsychotic medication of the pyridopyrroloquinoxaline and butyrophenone families. It is approved for the treatment of schizophrenia as well as bipolar depression, as either monotherapy or adjunctive therapy. It is developed by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb. Lumateperone was approved for medical use in the United States in December 2019 with an initial indication for schizophrenia, and became available in February 2020. It has since demonstrated efficacy in bipolar depression and received FDA approval in December 2021 for depressive episodes associated with both bipolar I and II disorders. Part of the drug shows structural similarity to Pirlindole. — Wikipedia
Clinical trial activity
24 trials · 6 clinical orgs · 6 marketing orgs
Earliest trial started Nov 2, 2017 (NCT03249376)
Timeline
2010s
- Jan 1, 2017
Intra-Cellular Therapies — Earliest Phase 3 Sponsor(trial)
- Dec 20, 2019
Intra-Cellular Therapies — Earliest FDA Approval
- Dec 20, 2019
Intra-Cellular Therapies — Marketing Organization
- Dec 20, 2019
Intra-Cellular Therapies — NDA Organization
2020s
- Jan 1, 2020
Intra-Cellular Therapies — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2022
Earliest Phase 2 Sponsor(trial)
- Mar 26, 2025
Aurobindo Pharma — Marketing Organization
- May 1, 2025
MSN Laboratories — Marketing Organization
- May 19, 2025
Hetero Labs Ltd — Marketing Organization
- May 27, 2025
Alkem Labs Ltd — Marketing Organization
- Aug 6, 2025
Dr. Reddy's Laboratories — Marketing Organization
Indications
Approved for
Mechanism of action
- Dopamine D2 receptorPARTIAL AGONIST
DRD2 partial agonist
Approval history
- approvedFast trackDec 20, 2019
Chemistry & pharmacology
SMILES
CN1CCN2c3c(cccc31)[C@@H]1CN(CCCC(=O)c3ccc(F)cc3)CC[C@@H]12.Cc1ccc(S(=O)(=O)O)cc1- Mol. weight
- 565.71 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaLumateperone ↗
- ChEMBLCHEMBL3233142 ↗
Also known as
- lumateperone
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06706674 | Phase 3 | Nov 30, 2024 | Intra-Cellular Therapies |
| NCT06690398 | Phase 3 | Nov 22, 2024 | Intra-Cellular Therapies |
| NCT06627413 | Phase 1 | Aug 23, 2024 | Intra-Cellular Therapies |
| NCT06462612 | Phase 3 | Jul 17, 2024 | Intra-Cellular Therapies |
| NCT06482554 | Phase 3 | Jun 30, 2024 | Louisiana State University |
| NCT06462586 | Phase 3 | Jun 19, 2024 | Intra-Cellular Therapies |
| NCT06372964 | Phase 3 | May 13, 2024 | Intra-Cellular Therapies |
| NCT06557902 | Phase 1 | May 10, 2024 | Intra-Cellular Therapies |
| NCT06229210 | Phase 3 | Jan 25, 2024 | Intra-Cellular Therapies |
| NCT06174116 | Phase 4 | Dec 31, 2023 | Intra-Cellular Therapies, University of Massachusetts |
| NCT05850689 | Phase 3 | May 31, 2023 | Intra-Cellular Therapies |
| NCT05890768 | Phase 4 | May 11, 2023 | University of New Mexico |
| NCT05732194 | Phase 1 | Jan 18, 2023 | Intra-Cellular Therapies, National Institute on Drug Abuse (NIDA) |
| NCT05356013 | Phase 2 | Jul 31, 2022 | Intra-Cellular Therapies, University of Chicago |
| NCT05470101 | Phase 1 | Jul 26, 2022 | Intra-Cellular Therapies, National Institute on Drug Abuse (NIDA) |
| NCT05061719 | Phase 3 | Sep 30, 2021 | Intra-Cellular Therapies |
| NCT05061706 | Phase 3 | Sep 30, 2021 | Intra-Cellular Therapies |
| NCT04985942 | Phase 3 | Jul 30, 2021 | Intra-Cellular Therapies |
| NCT04959032 | Phase 3 | Jul 8, 2021 | Intra-Cellular Therapies |
| NCT04779177 | Phase 1 | Mar 12, 2021 | Intra-Cellular Therapies |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Intra-Cellular Therapies | For profit | 22 | 20 | 4 | 2017 |
| National Institute on Drug Abuse (NIDA) | Government | 3 | 0 | 1 | 2021 |
| Louisiana State University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Chicago | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Massachusetts | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of New Mexico | Academic/Hospital | 1 | 1 | 1 | 2023 |
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alkem Labs Ltd | For profit | MKTG | May 27, 2025 |
| Aurobindo Pharma | For profit | MKTG | Mar 26, 2025 |
| Dr. Reddy's Laboratories | For profit | MKTG | Aug 6, 2025 |
| Hetero Labs Ltd | For profit | MKTG | May 19, 2025 |
| Intra-Cellular Therapies | For profit | MKTG | Dec 20, 2019 |
| Intra-Cellular Therapies | For profit | SYN | Dec 20, 2019 |
| Intra-Cellular Therapies | For profit | NDA | Dec 20, 2019 |
| MSN Laboratories | For profit | MKTG | May 1, 2025 |