iti-007
Lumateperone (ITI-722/ITI-007) is a dual 5HT2A receptor antagonist/dopamine phosphoprotein modulator (DPPM) for the treatment of schizophrenia. It is an orally available compound which combines potent 5HT2A receptor antagonism with cell-type-specific modulation of phosphoprotein pathways downstream of dopamine receptors. Lumateperone was developed by Intra-Cellular Therapies, Inc., and is being evaluated for the treatment of schizophrenia and bipolar depression. In 3 efficacy studies in patients with acute schizophrenia, lumateperone was well-tolerated with a favorable safety profile, and in 2 studies of 3 demonstrated significantly superior efficacy over placebo. — NCATS
Clinical trial activity
9 trials · 3 clinical orgs · 0 marketing orgs
Earliest trial started Dec 1, 2011 (NCT01499563)
Timeline
Indications
Mechanism of action
- Serotonin 2a (5-HT2a) receptorANTAGONIST
HTR2A antagonist
Chemistry & pharmacology
SMILES
CN1CCN2[C@H]3CCN(CCCC(=O)C4=CC=C(F)C=C4)C[C@H]3C5=C2C1=CC=C5- Mol. weight
- 393.497 g/mol
Oral
No
Parenteral
No
Topical
No
Sources
- NCATS70BSQ12069 ↗
- ChEMBLCHEMBL3545045 ↗
- ChEMBLCHEMBL3545044 ↗
Also known as
- iti-007
- iti-007
- iti-007
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03817528 | Phase 2 | Mar 1, 2019 | Columbia University, Intra-Cellular Therapies |
| NCT02817906 | Phase 3 | Jun 1, 2016 | Intra-Cellular Therapies |
| NCT02600494 | Phase 3 | Dec 1, 2015 | Intra-Cellular Therapies |
| NCT02600507 | Phase 3 | Dec 1, 2015 | Intra-Cellular Therapies |
| NCT02469155 | Phase 3 | Jun 1, 2015 | Intra-Cellular Therapies |
| NCT02282761 | Phase 3 | Nov 1, 2014 | Intra-Cellular Therapies |
| NCT02288845 | Phase 2 | Oct 1, 2014 | Intra-Cellular Therapies, Johns Hopkins University |
| NCT02078310 | Phase 1/Phase 2 (Phase 2) | Feb 1, 2014 | Intra-Cellular Therapies |
| NCT01499563 | Phase 2 | Dec 1, 2011 | Intra-Cellular Therapies |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Intra-Cellular Therapies | For profit | 9 | 8 | 2 | 2011 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2014 |