Drug

Clemastine

As of the edition of 20 October 2026, Clemastine is a small molecule: marketed, first approved in 1967 (CH); acts on HRH1.

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

The drug

Status
Marketed; latest approval 1982
Kind
Small molecule
Brand name
TAVIST-1
First approved
17 October 1967 (CH)
Approvals on record
10 in 2 regions
Holder of the most recent approval
Novartis; 3 holders in all
Registered trials
15, 2 stopped early
Disease areas
Immune system; Nervous system; Inherited and neonatal; Eye; Heart and blood vessels; Skin and connective tissue

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.

Target

GeneProteinUniProt
HRH1Histamine H1 receptorP35367

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2200
Phase 13210
Phase 26150
Phase 34102
All trials15

Who has held its approvals

CompanyRoleYears
NovartisApplicant and Lead sponsor of trials1989 to now
HaleonAcquired holder2024 to now
SandozEarlier holder