Last reviewed 2026-05-18 · How we verify

Dermovate® cream

LEO Pharma · Phase 1 active Small molecule Quality 60/100

Dermovate® cream is a Topical corticosteroid (ultra-high potency) Small molecule drug developed by LEO Pharma. It is currently in Phase 1 development.

Clobetasol propionate binds to glucocorticoid receptors to suppress inflammatory mediators and reduce skin inflammation.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Dermovate® cream
Sponsor	LEO Pharma
Drug class	Topical corticosteroid (ultra-high potency)
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Clobetasol propionate is a highly potent corticosteroid that binds to cytoplasmic glucocorticoid receptors. This complex then translocates to the nucleus where it modulates gene transcription, suppressing the production of inflammatory cytokines, prostaglandins, and leukotrienes, thereby reducing inflammation, itching, and redness in affected skin.

Approved indications

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dermovate® cream CI brief — competitive landscape report
Dermovate® cream updates RSS · CI watch RSS
LEO Pharma portfolio CI

Frequently asked questions about Dermovate® cream

What is Dermovate® cream?

Dermovate® cream is a Topical corticosteroid (ultra-high potency) drug developed by LEO Pharma.

How does Dermovate® cream work?

Clobetasol propionate binds to glucocorticoid receptors to suppress inflammatory mediators and reduce skin inflammation.

Who makes Dermovate® cream?

Dermovate® cream is developed by LEO Pharma (see full LEO Pharma pipeline at /company/leo-pharma).

What drug class is Dermovate® cream in?

Dermovate® cream belongs to the Topical corticosteroid (ultra-high potency) class. See all Topical corticosteroid (ultra-high potency) drugs at /class/topical-corticosteroid-ultra-high-potency.

What development phase is Dermovate® cream in?

Dermovate® cream is in Phase 1.

Drug class: All Topical corticosteroid (ultra-high potency) drugs
Manufacturer: LEO Pharma — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing