Drug

Cromolyn

As of the edition of 20 October 2026, Cromolyn is a small molecule: marketed, first approved in 1981 (CA).

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

The drug

Status
Marketed; latest approval 1988
Kind
Small molecule
Brand name
Intal
First approved
31 December 1981 (CA)
Approvals on record
10 in 4 regions
Holder of the most recent approval
Blacksmith Brands; 9 holders in all
Registered trials
18, 5 stopped early
Disease areas
Nervous system; Skin and connective tissue; Cancer; Lungs and airways; Digestive system; 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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 17421
Phase 28332
Phase 32002
Phase 41100
All trials18

Who has held its approvals

CompanyRoleYears
PfizerAcquired holder and Later holder1997 to now
AbbVieAcquired holder2003 to now
UCBAcquired holder2006 to now
SanofiAcquired holder2006 to now
Blacksmith BrandsAcquired holder2011 to now
ViatrisAcquired holder2025 to now
FisonsEarlier holder