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Adapalene BPO
Adapalene BPO is a Retinoid + peroxide combination Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Acne vulgaris.
Adapalene is a retinoid that binds to retinoic acid receptors to normalize skin cell differentiation and reduce inflammation, while benzoyl peroxide provides antimicrobial activity against acne-causing bacteria.
Adapalene is a retinoid that binds to retinoic acid receptors to normalize skin cell differentiation and reduce inflammation, while benzoyl peroxide provides antimicrobial activity against acne-causing bacteria. Used for Acne vulgaris.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Adapalene BPO |
|---|---|
| Sponsor | Galderma R&D |
| Drug class | Retinoid + peroxide combination |
| Target | Retinoic acid receptors (RAR); benzoyl peroxide (non-specific oxidizing agent) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Adapalene is a third-generation retinoid that selectively activates retinoic acid receptors, promoting keratinocyte differentiation and reducing comedone formation. Benzoyl peroxide acts as an oxidizing agent with bactericidal properties against Cutibacterium acnes. The combination targets both the inflammatory and bacterial components of acne pathogenesis.
Approved indications
- Acne vulgaris
Common side effects
- Erythema
- Dryness
- Peeling
- Irritation
- Photosensitivity
Key clinical trials
- Experience With Topical Acne Treatment (EARLY_PHASE1)
- Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel (PHASE2)
- MC RCT - BPO vs Adapalene (PHASE3)
- Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne (PHASE1, PHASE2)
- Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (PHASE4)
- Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris (PHASE4)
- Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris (PHASE4)
- Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Adapalene BPO CI brief — competitive landscape report
- Adapalene BPO updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about Adapalene BPO
What is Adapalene BPO?
How does Adapalene BPO work?
What is Adapalene BPO used for?
Who makes Adapalene BPO?
What drug class is Adapalene BPO in?
What development phase is Adapalene BPO in?
What are the side effects of Adapalene BPO?
What does Adapalene BPO target?
Related
- Drug class: All Retinoid + peroxide combination drugs
- Target: All drugs targeting Retinoic acid receptors (RAR); benzoyl peroxide (non-specific oxidizing agent)
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing