Drug

Doxylamine

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

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

The drug

Status
Marketed; latest approval 1987
Kind
Small molecule
Brand name
Decapryn
First approved
1 March 1967 (ES)
Approvals on record
11 in 5 regions
Holder of the most recent approval
Duchesnay; 7 holders in all
Registered trials
6, 0 stopped early
Disease areas
Ear, nose and throat; Immune system; Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive

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

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Doxylamine.

Target

GeneProteinUniProt
HRH1Histamine H1 receptorP35367

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2200
Phase 12200
Phase 31100
Phase 41100
All trials6

Who has held its approvals

CompanyRoleYears
BayerApplicant1986 to now
SanofiApplicant, Acquired holder and Earlier holder2008 to now
PfizerLater holder