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dapsone gel vehicle
dapsone gel vehicle is a Sulfone antibiotic with anti-inflammatory properties Small molecule drug developed by Almirall, S.A.. It is currently in Phase 3 development for Acne vulgaris (topical gel formulation).
Dapsone is a sulfone antibiotic that inhibits bacterial dihydropteroate synthase and has anti-inflammatory properties, reducing neutrophil migration and reactive oxygen species production.
Dapsone is a sulfone antibiotic that inhibits bacterial dihydropteroate synthase and has anti-inflammatory properties, reducing neutrophil migration and reactive oxygen species production. Used for Acne vulgaris (topical gel formulation).
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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 | dapsone gel vehicle |
|---|---|
| Sponsor | Almirall, S.A. |
| Drug class | Sulfone antibiotic with anti-inflammatory properties |
| Target | Dihydropteroate synthase; neutrophil function modulation |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Dapsone works through dual mechanisms: it inhibits folate synthesis in bacteria and has potent anti-inflammatory effects by suppressing neutrophil function and reducing the production of inflammatory mediators. In topical gel formulation, it is used to treat acne and other inflammatory skin conditions by reducing bacterial colonization and neutrophil-mediated inflammation in the skin.
Approved indications
- Acne vulgaris (topical gel formulation)
Common side effects
- Application site erythema
- Application site dryness
- Application site irritation
- Oiliness/seborrhea
Key clinical trials
- Randomized, Triple-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris (PHASE4)
- Phototoxicity Test of Dapsone Gel in Healthy Volunteers (PHASE1)
- Photoallergy Potential of Dapsone Gel in Healthy Volunteers (PHASE1)
- Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris (PHASE3)
- Dermal Tolerability of Dapsone Gel in Healthy Volunteers (PHASE1)
- A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris (PHASE3)
- Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE1)
- Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE1)
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:
- dapsone gel vehicle CI brief — competitive landscape report
- dapsone gel vehicle updates RSS · CI watch RSS
- Almirall, S.A. portfolio CI
Frequently asked questions about dapsone gel vehicle
What is dapsone gel vehicle?
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Related
- Drug class: All Sulfone antibiotic with anti-inflammatory properties drugs
- Target: All drugs targeting Dihydropteroate synthase; neutrophil function modulation
- Manufacturer: Almirall, S.A. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Acne vulgaris (topical gel formulation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing