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Melanex (METAHEXAMIDE)
Melanex (generic name: METAHEXAMIDE) is a metahexamide drug. It is currently in Phase 2 development for Chloasma, Discoloration of skin.
Melanex works by inhibiting the enzyme tyrosinase, which is involved in the production of melanin, the pigment responsible for skin color.
Melanex, also known as metahexamide, is a small molecule drug in the metahexamide class. It is used to treat Chloasma and skin discoloration. The commercial status of Melanex is currently unknown, and it is not clear if it is patented or available as a generic. Further information on its approval status, half-life, and bioavailability is also not available. As a result, key safety considerations and pharmacological details are not well established.
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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 | METAHEXAMIDE |
|---|---|
| Drug class | metahexamide |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 2 |
Mechanism of action
Think of melanin like the paint that colors your skin. Tyrosinase is the brush that helps spread the paint. Melanex blocks the brush, so less paint is applied, resulting in lighter skin color. This can help reduce the appearance of Chloasma and skin discoloration.
Approved indications
- Chloasma
- Discoloration of skin
Common side effects
Key clinical trials
- Incretin-based Drugs and Acute Pancreatitis
- Incretin-based Drugs and the Risk of Heart Failure
- Incretin-based Drugs and Pancreatic Cancer
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:
- Melanex CI brief — competitive landscape report
- Melanex updates RSS · CI watch RSS
Frequently asked questions about Melanex
What is Melanex?
How does Melanex work?
What is Melanex used for?
What is the generic name of Melanex?
What drug class is Melanex in?
What development phase is Melanex in?
Related
- Drug class: All metahexamide drugs
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Chloasma
- Indication: Drugs for Discoloration of skin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing