TheraRadar

Melanoma

Oncology 10 original drugs
10
Novel Drugs
4
Reformulations
521
Active Trials
19
Drug Targets

Oncology indication. Melanoma has 10 FDA-approved novel treatments, led by Roche, with 521 active industry clinical trials across 19 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Melanoma Market Leaders

Companies with the most FDA-approved novel Melanoma drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

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Q3 2026
HBI-8000 in combination with nivolumab
HUYABIO International, LLC.
Estimated · aging NCT04674683
Q1 2027
IDE196
IDEAYA Biosciences
Estimated · fresh NCT05987332
Q1 2027
BCD-217
Biocad
Estimated · aging NCT05751928
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Melanoma Treatments by Mechanism

Top 12 mechanisms across 89 industry trials with a known mechanism of action.

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Programmed Death Receptor-1 Blocking Antibody
38 trials 4 active 7 sponsors
ALK/ROS1/NTRK1/TRKB/TRKC
1 trials 1 active 1 sponsor
CTLA-4-directed Blocking Antibody
16 trials 3 sponsors
Kinase Inhibitor
15 trials 4 sponsors
GM-CSF
10 trials 2 sponsors
Programmed Death Ligand-1 Blocker
2 trials 2 sponsors
Azole Antifungal
2 trials 1 sponsor
Lymphocyte Growth Factor
1 trials 1 sponsor
Photoactivated Radical Generator
1 trials 1 sponsor
CD30-directed Immunoconjugate
1 trials 1 sponsor
Alkylating Drug
1 trials 1 sponsor
CD25-directed Cytotoxin
1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Melanoma Clinical Pipeline by Phase

731 industry-sponsored trials across 322 sponsors

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Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Melanoma

Reformulations (4 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Melanoma Drug Targets

Molecular targets of approved and investigational Melanoma drugs — 19 targets tracked.

Generic Drugs (1 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

Related Indications

Other Oncology indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology