loxapine
Trade name: loxitane
Small moleculeapproved
Approved
Feb 25, 1975
Loxapine is a dibenzoxazepine tricyclic antipsychotic agent, available for oral and inhalatory administration, classified as a typical antipsychotic. Loxapine acts as an antagonist at central serotonin and dopamine receptors. Adasuve (loxapine inhalation powder) is a prescription medicine that is used to treat acute agitation in adults with schizophrenia or bipolar I disorder. — NCATS
Clinical trial activity
22 trials · 19 clinical orgs · 9 marketing orgs
Phase 1
10
Phase 2
10
Phase 3
5
Phase 4
1
Earliest trial started Jan 1, 2003 (NCT00648778)
Timeline
1970s
1980s
- Jun 15, 1988
Watson Pharmaceuticals — Marketing Organization
2000s
- Jan 1, 2003
- Nov 1, 2004
Rising Pharmaceuticals — Marketing Organization
- Nov 1, 2004
Mylan — Marketing Organization
- Jan 1, 2005
Alexza Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 3 Sponsor(trial)
- Aug 4, 2005
Elite Laboratories, Inc — Marketing Organization
2010s
- Sep 26, 2011
Lannett Company, Inc. — Marketing Organization
- Dec 21, 2012
Galen — NDA Secondary Org
- Dec 21, 2012
Alexza Pharmaceuticals, Inc. — Marketing Organization
- Dec 21, 2012
Alexza Pharmaceuticals, Inc. — NDA Secondary Org
Indications
Approved for
Studied for
- Antipsychotic Agents · Phase 1
- Asthma · Phase 1
- Bipolar Disorder · Phase 3
- Cardiotoxicity · Phase 1
- Cigarette Smoking · Phase 1
- Emergence Delirium · Phase 3
- Healthy Volunteers · Phase 1
- Migraine Disorders · Phase 2
- Migraine with Aura · Phase 2
- Neuralgia · Phase 2
- Psychological Distress · Phase 3
- Psychomotor Agitation · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 1
- Schizophrenia · Phase 3
Mechanism of action
- Serotonin 2c (5-HT2c) receptorANTAGONIST
HTR2C antagonist
- Serotonin 2a (5-HT2a) receptorANTAGONIST
HTR2A antagonist
- D2-like dopamine receptorANTAGONIST
D2-like dopamine receptor antagonist
Approval history
- approvedFeb 25, 1975
Chemistry & pharmacology
Loading structure…
SMILES
CN1CCN(CC1)C2=NC3=CC=CC=C3OC4=CC=C(Cl)C=C24- Mol. weight
- 327.808 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Discontinued
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaLoxapine ↗
- NCATSLER583670J ↗
- ChEMBLCHEMBL831 ↗
- ChEMBLCHEMBL1201155 ↗
- ChEMBLCHEMBL1201060 ↗
Also known as
- 2-chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine
- 2-chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine
- adasuve
- adasuve
- adasuve
- cl-62362
- cl-62362
- cl-71563
- cl-71563
- cloxazepine
- cloxazepine
- cloxazepine
- loxapac
- loxapac
- loxapin
- loxapina
- loxapina
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine
- loxapine hcl
- loxapine hcl
- loxapine hcl
- loxapine hydrochloride
- loxapine hydrochloride
- loxapine hydrochloride
- loxapine hydrochloride
- loxapine succinate
- loxapine succinate
- loxapine succinate
- loxapine succinate
- loxapinum
- loxapinum
- loxipine maleate
- loxitane
- loxitane
- loxitane
- loxitane
- loxitane
- loxitane c
- loxitane c
- loxitane-c oral suspension [as hydrochloride]
- loxitane im
- loxitane im
- loxitane intramuscular [as hydrochloride]
- oxilapine
- oxilapine
- oxilapine
- sum 3170
- sum 3170
- sum-3170
- sum-3170
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05324852 | Phase 3 | Nov 15, 2022 | Assistance Publique - Hôpitaux de Paris, Hôpital Lariboisière |
| NCT04148963 | Phase 3 | Dec 1, 2019 | Lee's Pharmaceutical |
| NCT02820519 | Phase 2 | Jun 1, 2016 | Herdecke University, University of Witten/Herdecke |
| NCT02184767 | Phase 1 | Jul 1, 2014 | Teva |
| NCT01877642 | Phase 1 | Jun 1, 2013 | Alexza Pharmaceuticals, Inc., Covance |
| NCT01854710 | Phase 1 | May 1, 2013 | Alexza Pharmaceuticals, Inc., Pharmaceutical Research Associates, Inc. (PRA) |
| NCT01193816 | Phase 4 | May 1, 2011 | University of Paris |
| NCT00889837 | Phase 1 | Jun 1, 2009 | Alexza Pharmaceuticals, Inc. |
| NCT00890175 | Phase 1 | May 1, 2009 | Alexza Pharmaceuticals, Inc. |
| NCT00873769 | Phase 1 | Apr 1, 2009 | Alexza Pharmaceuticals, Inc., Covance |
| NCT00874237 | Phase 1 | Apr 1, 2009 | Alexza Pharmaceuticals, Inc., Covance |
| NCT00825500 | Phase 2 | Jan 1, 2009 | Alexza Pharmaceuticals, Inc., Clinvest, CNS Research, Inc., Elkind Headache Center |
| NCT00721955 | Phase 3 | Jul 1, 2008 | Alexza Pharmaceuticals, Inc. |
| NCT00628589 | Phase 3 | Feb 1, 2008 | Alexza Pharmaceuticals, Inc. |
| NCT00555412 | Phase 1 | Oct 1, 2007 | Alexza Pharmaceuticals, Inc., Atlanta Center for Medical Research |
| NCT00489476 | Phase 2 | Jun 1, 2007 | Alexza Pharmaceuticals, Inc., MedVadis Research Corporation |
| NCT00369577 | Phase 2 | Aug 1, 2006 | Alexza Pharmaceuticals, Inc. |
| NCT00122733 | N/A | Dec 1, 2005 | University of Paris |
| NCT00290082 | Phase 3 | Dec 1, 2005 | Rouen Normandy University |
| NCT00444028 | Phase 1 | Oct 1, 2005 | Alexza Pharmaceuticals, Inc., West Pharmaceutical Services |
Showing 20 of 22 trials
Page 1 / 2
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alexza Pharmaceuticals, Inc. | For profit | 14 | 14 | 3 | 2005 |
| Covance | For profit | 3 | 0 | 1 | 2009 |
| University of Paris | Academic/Hospital | 2 | 2 | 2 | 2005 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Atlanta Center for Medical Research | For profit | 1 | 0 | 1 | 2007 |
| Clinvest | For profit | 1 | 0 | 1 | 2009 |
| CNS Research, Inc. | For profit | 1 | 0 | 1 | 2009 |
| Elkind Headache Center | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Herdecke University | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Hôpital Lariboisière | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Kendle International Inc. | For profit | 1 | 0 | 1 | 2003 |
| Lee's Pharmaceutical | For profit | 1 | 1 | 1 | 2019 |
| MedVadis Research Corporation | For profit | 1 | 0 | 1 | 2007 |
| Mylan | For profit | 1 | 1 | 1 | 2003 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 1 | 0 | 1 | 2013 |
| Rouen Normandy University | Academic/Hospital | 1 | 1 | 1 | 2005 |
| Teva | For profit | 1 | 1 | 1 | 2014 |
| University of Witten/Herdecke | Academic/Hospital | 1 | 1 | 1 | 2016 |
| West Pharmaceutical Services | For profit | 1 | 0 | 1 | 2005 |
19 organizations
Page 1 / 1
Marketing (12)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | NDA2 | Oct 26, 1979 |
| Alexza Pharmaceuticals, Inc. | For profit | MKTG | Dec 21, 2012 |
| Alexza Pharmaceuticals, Inc. | For profit | NDA2 | Dec 21, 2012 |
| Elite Laboratories, Inc | For profit | MKTG | Aug 4, 2005 |
| Galen | For profit | NDA2 | Dec 21, 2012 |
| Lannett Company, Inc. | For profit | MKTG | Sep 26, 2011 |
| Mylan | For profit | MKTG | Nov 1, 2004 |
| Rising Pharmaceuticals | For profit | MKTG | Nov 1, 2004 |
| Rising Pharmaceuticals | For profit | SYN | Nov 1, 2004 |
| Teva | For profit | NDA2 | Feb 25, 1975 |
| Teva | For profit | NDA | Feb 25, 1975 |
| Watson Pharmaceuticals | For profit | MKTG | Jun 15, 1988 |