Drug

Loxapine

As of the edition of 20 October 2026, Loxapine is a small molecule: marketed, first approved in 1978 (FR); acts on DRD2, DRD3 and DRD4 and 1 more.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2013
Kind
Small molecule
Brand name
Loxitane
First approved
8 August 1978 (FR)
Approvals on record
12 in 3 regions
Holder of the most recent approval
Ferrer Internacional; 5 holders in all
Registered trials
23, 2 stopped early
Disease areas
Nervous system; Mental health; Lungs and airways; Immune system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

4 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

4 company-target rows are on route B because of Loxapine.

Targets

GeneProteinUniProt
DRD2Dopamine receptor D2P14416
DRD4Dopamine receptor D4P21917
HTR2A5-hydroxytryptamine receptor 2AP28223
DRD3Dopamine receptor D3P35462

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated4300
Phase 19900
Phase 24301
Phase 33200
Phase 43201
All trials23

Who has held its approvals

CompanyRoleYears
Nova PneumaAcquired holder and Lead sponsor of trials2009 to now
Ferrer InternacionalApplicant2013 to now
TevaAcquired holder and Lead sponsor of trials2014 to now
Actavis Laboratories UtAcquired holder2015 to now
PfizerEarlier holder