Drugs / loxapine
loxapine
also known as
Staccato Loxapine · ADASUVE · CL 62,362 · CL 71563 · Loxapac · Loxapina · Loxapine hcl · LOXAPINE HYDROCHLORIDE · +6 more
Small molecule targets HTR2A, HTR2C via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Adasuve | — | 2013-02-20 | europa.eu ↗ |
| Label expansion | US (FDA) | LOXITANE | — | 1983-03-10 | fda.gov ↗ |
| Approved | US (FDA) | LOXITANE | — | 1975-02-25 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 2 met primary · 1 missed | ||||||
| Phase 1 | NCT02184767 | Jul 2014 → Mar 2015 | bipolar disorder | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00889837 | Jun → Aug 2009 | chronic obstructive pulmonary disease | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00890175 | May → Aug 2009 | asthma | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00874237 | Apr → Jun 2009 | — | Nova Pneuma Inc. | Completed | Met primary |
| Phase 1 | NCT00873769 | Apr → Jun 2009 | — | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00789360 | Nov 2008 → Apr 2009 | — | Alexza Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 1 | NCT00555412 | Oct → Dec 2007 | — | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00444028 | Sep → Nov 2005 | schizophrenia | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 1 | NCT00648778 | Jan → Feb 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT02820519 | Jun 2016 → May 2017 | neuropathy, painful | University of Witten/Herdecke | Terminated | No outcome recorded |
| Phase 2 | NCT00489476 | Jun → Dec 2007 | migraine disorder | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00369577 | Aug 2006 → Jan 2007 | schizophrenia | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04148963 | Dec 2019 → May 2020 | bipolar disorder, schizophrenia | Lee's Pharmaceutical Limited | Unknown | No outcome recorded |
| Phase 3 | NCT00721955 | Jul → Oct 2008 | bipolar I disorder | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT00628589 | Feb → May 2008 | — | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 44 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT03110900 | Sep 2017 → Apr 2018 | — | University of Arkansas | Terminated | No outcome recorded |
| Phase 4 | NCT01877642 | Jun → Jul 2013 | — | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 4 | NCT01854710 | May → Jul 2013 | — | Alexza Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 4 | NCT01193816 | May 2011 → May 2014 | — | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT00122733 | Dec 2005 → Dec 2006 | respiratory failure | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT00825500 Comparator | Jan → Aug 2009 | migraine disorder | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05324852 Comparator | Apr 2023 | delirium | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00290082 Comparator | Dec 2005 → Oct 2007 | — | University Hospital, Rouen | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-12-04 | Lee's Pharmaceutical Limited | Regulatory The Group’s in-licensed product Adasuve® (Loxapine for Inhalation) obtained Drug Registration Certificate leespharm.com ↗
28 November 2023, Lee's Pharmaceutical Holdings Limited ("Lee's Pharm" or the "Group", HKEx:00950) announced that the Drug Registration Certificate for Adasuve® (Loxapine for Inhalation) had been obtained from the China National Medical Products Administration (“NMPA”) for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-04-02 | Eisai Inc. | FRENCH SALES SUBSIDIARY EISAI S.A.S. TO DIVEST RIGHTS FOR LOXAPAC® AND PARKINANE® LP TO CNX THERAPEUTICS eisai.com ↗ |
| 2023-12-04 | Lee's Pharmaceutical Limited | The Group’s in-licensed product Adasuve® (Loxapine for Inhalation) obtained Drug Registration Certificate leespharm.com ↗ |
| 2014-04-30 | Medivir | Adasuve will now be launched in Sweden, Norway, Finland and Denmark medivir.com ↗ |
| 2014-03-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Launches ADASUVE® in U.S. tevapharm.com ↗ |
| 2013-05-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S. tevapharm.com ↗ |
| 2011-09-27 | Lannett Company, Inc. | Lannett receives fda approval for Loxapine capsules, 5 mg, 10 mg, 25 mg and 50 mg Lannett receives fda approval for Loxapine capsules, 5 mg, 10 mg, 25 mg and 50 mg investorroom.com ↗ |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | loxapine | “Inhaled loxapine 10 mg 2 doses 2 hours apart” NCT01854710 ↗ |
| Known as | ADASUVE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02184767 ↗ |
| Known as | CL 62,362 | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | CL 71563 | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxapac | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxapina | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxapine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | LOXAPINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxapine Succinate | “Loxapine Succinate Capsules 25 mg” NCT00648778 ↗ |
| Known as | Loxitane | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxitane c | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Loxitane im | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | NSC-759578 | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Known as | Staccato Loxapine | “The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy...” NCT00444028 ↗5“The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.” NCT00489476 ↗ “A Study of Staccato Loxapine (ADASUVE®) for Inhalation” NCT04148963 ↗ “Staccato Loxapine, 10 mg x 2 doses, 10 hours apart” NCT00889837 ↗ “2 dose levels of Staccato Loxapine, 5 and 10 mg.” NCT00721955 ↗ “Inhaled Staccato Loxapine 10 mg single dose” NCT00874237 ↗ |
| Known as | SUM 3170 | ChEMBL registry synonym — accepted as the source's own label CHEMBL831 ↗ |
| Action | Inhibit | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL831 ↗1“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL831 ↗ |
| Modality | Small molecule | — CHEMBL831 ↗ |
| Route | Other | “loxapine by the nasogastric tube” NCT00122733 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL831 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL831 ↗ |