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Acanya Gel
Acanya Gel is a Topical antibiotic combination Small molecule drug developed by Padagis LLC. It is currently in Phase 3 development for Acne vulgaris. Also known as: Reference product.
Acanya Gel combines clindamycin (an antibiotic) and benzoyl peroxide (an antimicrobial oxidizing agent) to reduce acne-causing bacteria and decrease sebum production.
Acanya Gel combines clindamycin (an antibiotic) and benzoyl peroxide (an antimicrobial oxidizing agent) to reduce acne-causing bacteria and decrease sebum production. 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 | Acanya Gel |
|---|---|
| Also known as | Reference product |
| Sponsor | Padagis LLC |
| Drug class | Topical antibiotic combination |
| Target | Cutibacterium acnes (bacterial protein synthesis inhibition); benzoyl peroxide acts as an oxidizing antimicrobial |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Clindamycin inhibits bacterial protein synthesis, killing Cutibacterium acnes and other acne-associated bacteria. Benzoyl peroxide generates reactive oxygen species that further reduce bacterial load and have keratolytic properties. Together, these agents address both the bacterial and inflammatory components of acne.
Approved indications
- Acne vulgaris
Common side effects
- Erythema
- Dryness
- Peeling
- Irritation at application site
Key clinical trials
- A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (PHASE4)
- Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations (NA)
- Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty (PHASE4)
- Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris (PHASE4)
- A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris (PHASE3)
- Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels (PHASE3)
- To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel (PHASE3)
- Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris (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:
- Acanya Gel CI brief — competitive landscape report
- Acanya Gel updates RSS · CI watch RSS
- Padagis LLC portfolio CI
Frequently asked questions about Acanya Gel
What is Acanya Gel?
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Is Acanya Gel also known as anything else?
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What does Acanya Gel target?
Related
- Drug class: All Topical antibiotic combination drugs
- Target: All drugs targeting Cutibacterium acnes (bacterial protein synthesis inhibition); benzoyl peroxide acts as an oxidizing antimicrobial
- Manufacturer: Padagis LLC — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris
- Also known as: Reference product
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing