lurasidone
Trade name: latuda
Approved
Oct 28, 2010
Lurasidone is a novel antipsychotic agent approved for the treatment of schizophrenia in a number of countries including the UK and is also approved in the USA and Canada for the treatment of bipolar depression as either a monotherapy or adjunctive therapy with lithium or valproate. In addition, lurasidone is in phase III of a clinical trial for the treatment patient with major depressive disorder and for the treatment of irritability associated with autistic disorder. The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown but is known, that lurasidone has a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. — NCATS
Clinical trial activity
77 trials · 38 clinical orgs · 30 marketing orgs
Earliest trial started Jul 1, 2002 (NCT00044044)
Timeline
2000s
2010s
- Oct 28, 2010
Sumitomo Dainippon — Earliest FDA Approval
- Oct 28, 2010
Sunovion — NDA Secondary Org
- Oct 28, 2010
Sumitomo Dainippon — NDA Organization
- Jan 25, 2016
MSN Laboratories — Marketing Organization
- Feb 23, 2016
Emcure — Marketing Organization
- Nov 18, 2016
Aurobindo Pharma — Marketing Organization
- Dec 5, 2016
Watson Pharmaceuticals — Marketing Organization
- May 19, 2017
Par Pharmaceuticals — Marketing Organization
- May 19, 2017
Bristol-Myers Squibb — Marketing Organization
- Jan 3, 2019
Accord Research — Marketing Organization
- Jan 3, 2019
Amneal Pharmaceuticals — Marketing Organization
- Jan 3, 2019
Invagen Pharms — Marketing Organization
- Jan 3, 2019
Lupin — Marketing Organization
- Jan 3, 2019
Torrent Pharmaceuticals Limited — Marketing Organization
- Jan 3, 2019
Cipla — Marketing Organization
- Jan 4, 2019
Sun Pharmaceuticals — Marketing Organization
- Mar 19, 2019
Zydus Discovery DMCC — Marketing Organization
- May 17, 2019
Teva — Marketing Organization
- Sep 4, 2019
Heritage Pharma — Marketing Organization
- Sep 4, 2019
Avet Lifesciences — Marketing Organization
2020s
- Mar 9, 2020
Alkem Labs Ltd — Marketing Organization
- Dec 28, 2020
Adaptis Pharma — Marketing Organization
- Dec 28, 2020
Piramal — Marketing Organization
- Dec 28, 2020
SLATE RUN PHARMA — Marketing Organization
- Dec 28, 2020
Chartwell Pharmaceuticals — Marketing Organization
- May 13, 2021
Alembic — Marketing Organization
- Aug 24, 2021
Dr. Reddy's Laboratories — Marketing Organization
- Jun 9, 2023
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Jun 9, 2023
Neogen — Marketing Organization
- Aug 21, 2024
Annora Pharma — Marketing Organization
- Dec 6, 2024
Jubilant Innovation Ltd. — Marketing Organization
Indications
Approved for
Studied for
- Asperger Syndrome · Phase 2
- Autistic Disorder · Phase 3
- Bipolar Disorder · Phase 4
- Child Development Disorders, Pervasive · Phase 2
- Depression · Phase 4
- Depressive Disorder, Treatment-Resistant · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Major Depressive Disorder · Phase 3
- Mania · Phase 4
- Mental Health · Phase 2
- Metabolism · Phase 1
- Mood Disorders · Phase 2
- Pharmacokinetics · Phase 1
- Pyelonephritis · Phase 2
- Suicidal Ideation · Phase 2/Phase 3
- Suicide · Phase 2/Phase 3
- Suicide, Attempted · Phase 2/Phase 3
- Urinary Tract Infections · Phase 2
Mechanism of action
- Serotonin 2a (5-HT2a) receptorANTAGONIST
HTR2A antagonist
- Dopamine D2 receptorANTAGONIST
DRD2 antagonist
Approval history
- approvedOct 28, 2010
Chemistry & pharmacology
SMILES
O=C1[C@@H]2[C@H]3CC[C@H](C3)[C@@H]2C(=O)N1C[C@@H]1CCCC[C@H]1CN1CCN(c2nsc3ccccc23)CC1- Mol. weight
- 492.69 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
- ChEMBLCHEMBL1237021 ↗
- WikipediaLurasidone ↗
- NCATS22IC88528T ↗
- ChEMBLCHEMBL1615372 ↗
Also known as
- latuda
- latuda
- latuda
- latuda
- lurasidona
- lurasidona
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone
- lurasidone hcl
- lurasidone hcl
- lurasidone hcl
- lurasidone hydrochloride
- lurasidone hydrochloride
- lurasidone hydrochloride
- lurasidone hydrochloride
- lurasidonum
- lurasidonum
- sm-13496
- sm-13496
- sm-13496
- sm-13496
- sm-13496
- sm-13496
- sm-13496
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07227103 | Phase 2/Phase 3 (Phase 3) | Mar 1, 2026 | NeuroRx, Inc. |
| NCT06825169 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2025 | Jiao Tong University, Nuwacell Biotechnologies Co., Ltd. |
| NCT06433635 | Phase 4 | Sep 1, 2024 | Harvard University, Patient-Centered Outcomes Research Institute |
| NCT06128213 | Phase 2 | Mar 31, 2024 | NeuroRx, Inc. |
| NCT05213143 | Phase 4 | Jan 31, 2022 | Sumitomo |
| NCT05351736 | Phase 4 | Jan 26, 2022 | A.O. Ospedale Maggiore di Lodi |
| NCT05480150 | N/A | Nov 1, 2021 | Zhejiang University |
| NCT05011669 | Phase 4 | Aug 16, 2021 | Sumitomo |
| NCT04383691 | Phase 3 | Jun 30, 2020 | Capital Medical University, Sumitomo, Sunovion |
| NCT03786614 | N/A | Feb 28, 2019 | University of Louisville |
| NCT03902613 | Phase 4 | Feb 7, 2019 | Columbia University |
| NCT03557931 | Phase 2 | Jul 13, 2018 | Astellas |
| NCT03627195 | Phase 1 | Jun 7, 2018 | Sunovion |
| NCT03396068 | Phase 2/Phase 3 (Phase 3) | May 1, 2018 | Bracket Global, NeuroRx, Inc., Stats Collaborative, Target Health Inc. |
| NCT03465787 | Phase 3 | Apr 9, 2018 | Bukwang Pharmaceutical, Seoul National University |
| NCT03395392 | Phase 2/Phase 3 (Phase 3) | Apr 1, 2018 | Bracket Global, NeuroRx, Inc., Stats Collaborative, Target Health Inc. |
| NCT03402152 | Phase 2/Phase 3 (Phase 3) | Mar 15, 2018 | NeuroRx, Inc., Target Health Inc. |
| NCT03393026 | Phase 4 | Jan 31, 2018 | Standard Chem. & Pharm. Co., Ltd. |
| NCT03304457 | Phase 4 | Aug 25, 2017 | All India Institute of Medical Sciences |
| NCT02974010 | Phase 2/Phase 3 (Phase 3) | Jun 15, 2017 | Harvard University, NeuroRx, Inc., Target Health Inc. |
Organizations
Research & Development (38)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sunovion | For profit | 42 | 38 | 5 | 2002 |
| NeuroRx, Inc. | For profit | 7 | 7 | 3 | 2017 |
| Sumitomo | For profit | 6 | 6 | 3 | 2013 |
| Sumitomo Dainippon | For profit | 6 | 5 | 1 | 2008 |
| Target Health Inc. | For profit | 4 | 0 | 1 | 2017 |
| Harvard University | Academic/Hospital | 3 | 2 | 2 | 2017 |
| Parexel | For profit | 3 | 0 | 1 | 2008 |
| Bracket Global | For profit | 2 | 0 | 1 | 2018 |
| California Clinical Trials | For profit | 2 | 0 | 1 | 2008 |
| Columbia University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Shanghai Xuhui District Central Hospital | Academic/Hospital | 2 | 0 | 1 | 2014 |
| Stats Collaborative | For profit | 2 | 0 | 1 | 2018 |
| The University of Texas, Dallas | Academic/Hospital | 2 | 2 | 1 | 2013 |
| University of British Columbia | Academic/Hospital | 2 | 2 | 1 | 2014 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 2 | 1 | 2 | 2009 |
| All India Institute of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2017 |
| A.O. Ospedale Maggiore di Lodi | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Astellas | For profit | 1 | 1 | 1 | 2018 |
| Bukwang Pharmaceutical | For profit | 1 | 1 | 1 | 2018 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2020 |
Marketing (36)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Jan 3, 2019 |
| Adaptis Pharma | For profit | MKTG | Dec 28, 2020 |
| Alembic | For profit | MKTG | May 13, 2021 |
| Alembic | For profit | SYN | May 13, 2021 |
| Alkem Labs Ltd | For profit | MKTG | Mar 9, 2020 |
| Amneal Pharmaceuticals | For profit | MKTG | Jan 3, 2019 |
| Annora Pharma | For profit | MKTG | Aug 21, 2024 |
| Aurobindo Pharma | For profit | MKTG | Nov 18, 2016 |
| Avet Lifesciences | For profit | MKTG | Sep 4, 2019 |
| Bristol-Myers Squibb | For profit | MKTG | May 19, 2017 |
| Chartwell Pharmaceuticals | For profit | MKTG | Dec 28, 2020 |
| Cipla | For profit | MKTG | Jan 3, 2019 |
| Dr. Reddy's Laboratories | For profit | SYN | Aug 24, 2021 |
| Dr. Reddy's Laboratories | For profit | MKTG | Aug 24, 2021 |
| Emcure | For profit | MKTG | Feb 23, 2016 |
| Heritage Pharma | For profit | MKTG | Sep 4, 2019 |
| Invagen Pharms | For profit | MKTG | Jan 3, 2019 |
| Jubilant Innovation Ltd. | For profit | MKTG | Dec 6, 2024 |
| Lupin | For profit | MKTG | Jan 3, 2019 |
| Lupin | For profit | SYN | Jan 3, 2019 |
| MSN Laboratories | For profit | SYN | Sep 9, 2022 |
| MSN Laboratories | For profit | MKTG | Jan 25, 2016 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Jun 9, 2023 |
| Neogen | For profit | MKTG | Jun 9, 2023 |
| Par Pharmaceuticals | For profit | MKTG | May 19, 2017 |
| Piramal | For profit | MKTG | Dec 28, 2020 |
| SLATE RUN PHARMA | For profit | MKTG | Dec 28, 2020 |
| Sumitomo Dainippon | For profit | NDA | Oct 28, 2010 |
| Sun Pharmaceuticals | For profit | MKTG | Jan 4, 2019 |
| Sun Pharmaceuticals | For profit | SYN | Jan 4, 2019 |
| Sunovion | For profit | NDA2 | Oct 28, 2010 |
| Teva | For profit | SYN | Feb 2, 2021 |
| Teva | For profit | MKTG | May 17, 2019 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jan 3, 2019 |
| Watson Pharmaceuticals | For profit | MKTG | Dec 5, 2016 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 19, 2019 |