Drug

Beclomethasone dipropionate

As of the edition of 20 October 2026, Beclomethasone dipropionate is a small molecule: marketed, first approved in 1968 (ES); acts on NR3C1; no US protection of its own is listed.

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

The drug

Status
Marketed; latest approval 1998
Kind
Small molecule
Brand name
Beclovent
First approved
1 January 1968 (ES)
Approvals on record
22 in 4 regions
Holder of the most recent approval
Chiesi Farmaceutici; 7 holders in all
Registered trials
79, 6 stopped early
Disease areas
Lungs and airways; Immune system; Ear, nose and throat; Infections; Inherited and neonatal; Urinary and reproductive

US protection

No US protection of its own is listed.

The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.

Chiesi Farmaceutici holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.

This is the US only.

Companies that need a new molecule because of this drug

3 companies on route B because of this drug.

Companies on route B for this drug

In the product

3 companies are on route B because of Beclomethasone dipropionate.

Target

GeneProteinUniProt
NR3C1Glucocorticoid receptorP04150

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated171222
Phase 15500
Phase 2131102
Phase 3302910
Phase 4141112
All trials79

Who has held its approvals

CompanyRoleYears
Bausch HealthAcquired holder1998 to now
3MLater holder2000 to now
TevaAcquired holder and Lead sponsor of trials2004 to now
Chiesi FarmaceuticiLater holder and Lead sponsor of trials2006 to now
GSKLater holder and Lead sponsor of trials2006 to now
Norton WaterfordLater holder2017 to now
Merck & Co.Applicant