Last reviewed · How we verify
Mechlorethamine Topical Gel
Mechlorethamine Topical Gel is a Small molecule drug developed by Soligenix. It is currently in Phase 2 development. Also known as: Valchlor.
Mechlorethamine Topical Gel is a small molecule DNA inhibitor used to treat various skin conditions, including Chronic Spontaneous Urticaria, Hidradenitis Suppurativa, Psoriasis, Atopic Dermatitis, and Cutaneous T-cell lymphoma/Mycosis Fungoides. It is available as a 0.016% topical gel formulation, which has been studied in clinical trials alongside other interventions such as Triamcinolone and Valchlor.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Mechlorethamine Topical Gel |
|---|---|
| Also known as | Valchlor |
| Sponsor | Soligenix |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- StrataCTX® as a Steroid Sparing Device (NA)
- HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (PHASE2)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System. (NA)
- REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (PHASE2)
- Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides (NA)
- Mechlorethamine Induced Contact Dermatitis Avoidance Study (PHASE2)
- Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides (PHASE2)
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:
- Mechlorethamine Topical Gel CI brief — competitive landscape report
- Mechlorethamine Topical Gel updates RSS · CI watch RSS
- Soligenix portfolio CI
Frequently asked questions about Mechlorethamine Topical Gel
What is Mechlorethamine Topical Gel?
Who makes Mechlorethamine Topical Gel?
Is Mechlorethamine Topical Gel also known as anything else?
What development phase is Mechlorethamine Topical Gel in?
Related
- Manufacturer: Soligenix — full pipeline
- Also known as: Valchlor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing