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Methotrexate 1% Topical Gel
Methotrexate inhibits dihydrofolate reductase, blocking folate metabolism and reducing DNA synthesis in rapidly dividing cells, with immunosuppressive and anti-inflammatory effects when applied topically.
Methotrexate inhibits dihydrofolate reductase, blocking folate metabolism and reducing DNA synthesis in rapidly dividing cells, with immunosuppressive and anti-inflammatory effects when applied topically. Used for Psoriasis, Inflammatory skin conditions, Cutaneous T-cell lymphoma (mycosis fungoides).
At a glance
| Generic name | Methotrexate 1% Topical Gel |
|---|---|
| Sponsor | Jinnah Postgraduate Medical Centre |
| Drug class | Antimetabolite; Immunosuppressant |
| Target | Dihydrofolate reductase (DHFR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
As a topical formulation, methotrexate penetrates skin tissue to inhibit dihydrofolate reductase, disrupting purine and pyrimidine synthesis. This reduces proliferation of keratinocytes and immune cells in the dermis and epidermis. The anti-inflammatory and immunosuppressive properties make it effective for inflammatory and proliferative skin conditions.
Approved indications
- Psoriasis
- Inflammatory skin conditions
- Cutaneous T-cell lymphoma (mycosis fungoides)
Common side effects
- Local skin irritation
- Erythema
- Pruritus
- Burning sensation
Key clinical trials
- Topical Methotrexate vs Minoxidil for Localized Alopecia Areata (PHASE4)
- Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients (NA)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- Topical Methotrexate with Fractional CO2 Laser in Treatment of Non Segmental Vitiligo (NA)
- Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis (EARLY_PHASE1)
- The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo (PHASE3)
- Efficacy and Safety of Topical Methotrexate Gel 1% Coupled With Microneedling in Treatment of Warts (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:
- Methotrexate 1% Topical Gel CI brief — competitive landscape report
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- Jinnah Postgraduate Medical Centre portfolio CI