Drug

Zotepine

As of the edition of 20 October 2026, Zotepine is a small molecule: marketed.

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

The drug

Status
Marketed
Kind
Small molecule
Brand name
Zoleptil
Approvals on record
2 in 2 regions
Holder of the most recent approval
Teva; 2 holders in all
Registered trials
3, 2 stopped early
Disease areas
Mental health; Nervous 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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1100
Phase 42002
All trials3

Who ran its trials

CompanyRoleYears
AstellasLead sponsor of trials2007 to now
OrganonLead sponsor of trials2013 to now