Diprolene

(betamethasone dipropionate)

Phase 2Small molecule

PPrimus Pharmaceuticals

Diprolene is one of 86 small molecule programs targeting Oral Lichen Planus. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Oral Lichen PlanusActive, not recruiting

Oral Submucous FibrosisActive, not recruiting

PsoriasisActive, not recruiting

Atopic DermatitisActive, not recruiting

Oral Lichen PlanusPhase 2

Active, not recruiting

Oral Submucous FibrosisPhase 1/Phase 2

Active, not recruiting

PsoriasisPhase 2

Active, not recruiting

Atopic DermatitisPhase 1

Active, not recruiting

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Diprolene

PPrimus Pharmaceuticals

Phase 2

1 2

Taltz

Eli Lilly

Preclinical

20 3

Bimzelx

UCB

Preclinical

17 4

Humira

CCelltrion

Preclinical

42 5

Ilumya

Sun Pharmaceutical Industries, Inc.

Preclinical

15 6

Raptiva

Roche

Preclinical

10 7

Remicade

OOrganon and Co

Preclinical

20 8

Victoza

Novo Nordisk

Preclinical

2 9

Lovenox

Sanofi

Preclinical

1 10

Olux

HHarrow Inc

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Oral Submucous Fibrosis1 trial

Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial

Completed·ZZiauddin University·Phase 1/2·NCT06332612·30 enrolled

Oral Lichen Planus1 trial

Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

Unknown status·GGarlapati Komali·Phase 2·NCT03026478·30 enrolled

Atopic Dermatitis1 trial

A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT02376049·30 enrolled

Psoriasis1 trial

A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products

Completed· LEO Pharma logo

LEO Pharma·Phase 2·NCT00875277·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DIPROSONE

NDA NDA017781

Jan 1, 1982

DIPROSONE

NDA NDA017829

Jan 1, 1982

DIPROSONE

NDA NDA017691

Jan 1, 1982

DIPROSONE

NDA NDA017536

Jul 27, 1983

DIPROLENE

NDA NDA018741

Jun 26, 1984

ALPHATREX

NDA NDA019138

Jun 26, 1984

BETAMETHASONE DIPROPIONATE

NDA NDA019137

Jun 26, 1984

BETAMETHASONE DIPROPIONATE

NDA NDA019136

Sep 4, 1984

BETAMETHASONE DIPROPIONATE

NDA NDA019141

Sep 4, 1984

ALPHATREX

NDA NDA019143

Sep 4, 1984

BETAMETHASONE DIPROPIONATE

NDA NDA019140

Jan 31, 1986

DIPROLENE

NDA NDA019408

Apr 27, 1987

DIPROLENE AF

NDA NDA019555

Aug 1, 1988

DIPROLENE

NDA NDA019716

Feb 5, 2016

SERNIVO

NDA NDA208079

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for betamethasone dipropionate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — betamethasone dipropionate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for betamethasone dipropionate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208079). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Diprolene. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Primus Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: PPrimus Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Aug 31, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9775851Aug 31, 2030

9364485Aug 31, 2030

9655907Aug 31, 2030

10179137Aug 31, 2030

9433630Aug 31, 2030

2 more patents

9877974Aug 31, 2030

9439911Aug 31, 2030

Diprolene

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Oral Submucous Fibrosis1 trial

Oral Lichen Planus1 trial

Atopic Dermatitis1 trial

Psoriasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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