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ketoconazole shampoo (2/week)
ketoconazole shampoo (2/week) is a Imidazole antifungal Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Dandruff and seborrheic dermatitis of the scalp.
Ketoconazole shampoo inhibits fungal growth by disrupting ergosterol synthesis in fungal cell membranes, reducing dandruff and seborrheic dermatitis.
Ketoconazole shampoo inhibits fungal growth by disrupting ergosterol synthesis in fungal cell membranes, reducing dandruff and seborrheic dermatitis. Used for Dandruff and seborrheic dermatitis of the scalp.
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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 | ketoconazole shampoo (2/week) |
|---|---|
| Sponsor | Galderma R&D |
| Drug class | Imidazole antifungal |
| Target | Fungal lanosterol 14α-demethylase (CYP51) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ketoconazole is an imidazole antifungal that blocks the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, preventing conversion of lanosterol to ergosterol. This disrupts the integrity of the fungal cell membrane, leading to cell death. When formulated as a topical shampoo, it directly targets Malassezia and other scalp fungi responsible for dandruff and seborrheic dermatitis.
Approved indications
- Dandruff and seborrheic dermatitis of the scalp
Common side effects
- Scalp irritation
- Pruritus
- Dry scalp
- Hair loss (rare)
Key clinical trials
- 8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor (PHASE4)
- To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases (PHASE3)
- Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis (NA)
- Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis (PHASE3)
- The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial (PHASE4)
- Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo (NA)
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:
- ketoconazole shampoo (2/week) CI brief — competitive landscape report
- ketoconazole shampoo (2/week) updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about ketoconazole shampoo (2/week)
What is ketoconazole shampoo (2/week)?
How does ketoconazole shampoo (2/week) work?
What is ketoconazole shampoo (2/week) used for?
Who makes ketoconazole shampoo (2/week)?
What drug class is ketoconazole shampoo (2/week) in?
What development phase is ketoconazole shampoo (2/week) in?
What are the side effects of ketoconazole shampoo (2/week)?
What does ketoconazole shampoo (2/week) target?
Related
- Drug class: All Imidazole antifungal drugs
- Target: All drugs targeting Fungal lanosterol 14α-demethylase (CYP51)
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Dandruff and seborrheic dermatitis of the scalp
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing