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Drug Pipeline Review Therapy area: Melanoma40–50 pages · PDF + Excel tracker

Melanoma Drug Pipeline: 401 Assets by Phase

Melanoma pipeline: 401 drug candidates in clinical development, 42 in Phase III, from 190 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Melanoma Data as of 3 Oct 2026
Candidates in development 401assets Desk-reviewed How this number is madeEvery drug named in an interventional trial, merged across code, generic and brand names, with a live or recent industry trial. Placebo and comparator arms excluded.
Phase III 4210% of pipeline Registry How this number is madeCandidates whose highest phase in a live or recent trial is Phase III (Phase II/III counts as Phase II).
Phase II 9323% of pipeline Registry
Phase I 26666% of pipeline Registry
Sponsors 190top 5 hold 12% Registry How this number is madeCompanies credited with at least one candidate: the lead sponsor on most of that candidate's industry trials.
Registered trials 1,463582 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 3 Oct 2021.
Readouts in 12 months 35Phase II or later Sponsor dates How this number is madeCandidates with a registered primary completion date in the next 12 months. Dates are the sponsor's own and often move.
Trials with US sites 94465% · Europe 31% Registry How this number is madeTrials with at least one site in the United States; Europe is the EU/EEA, the UK and Switzerland. A trial counts in every region where it has a site.

Candidates by highest phase reached

Phase I266
Phase II93
Phase III42

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
VV1Phase IIOct 2026 (est.)
CemiplimabPhase IIOct 2026 (est.)
EncorafenibPhase IIIOct 2026 (est.)

Candidates in development by lead sponsor

Modulation Therapeutics, Inc.12
Merck Sharp & Dohme LLC12
Bristol-Myers Squibb9
Novartis Pharmaceuticals9
Hoffmann-La Roche8

Phase II and III primary completions per quarter

Q4 202611
Q1 202712
Q2 20278
Q3 20274
Q4 202720
Q1 20285
Q2 20285
Q3 20289

Answers at a glance

  • 42 of 401 melanoma candidates (10%) are in Phase III.
  • Modulation Therapeutics, Inc. runs the largest melanoma pipeline, with 12 candidates.
  • 35 readouts are due in 12 months; the next is VV1 in Oct 2026.
  • 286 trials are recruiting patients now; 65% of all trials have a US site and 31% a European one.
401 candidates1,463 trials67 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Edition: data as of 3 Oct 2026 Next refresh: by 1 Jan 2027 Change: First edition

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A sample of the Melanoma Pipeline Review: the full chapter list, the tracker columns and two asset profiles from the report. The Research Desk reviews your request and emails it, usually within one business day.

Melanoma has 401 drug candidates in active clinical development, of which 42 are in Phase III, 93 in Phase II and 266 in Phase I, according to Douglas Insights' count of 1,463 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The melanoma drug pipeline is the set of medicines that sponsors are still testing in people for this condition: each candidate is counted once, at the highest phase it has reached in a running or recently completed trial. Medicines already on the market and studied only in Phase IV trials are kept out of the count.

How many melanoma drugs are in each phase of development?

Douglas Insights counts 42 melanoma candidates in Phase III, 10% of the 401 assets in development; Phase II holds 93 and Phase I holds 266.

Phase I266Phase II93Phase III42
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III4210%
Phase II9323%
Phase I26666%
Total401100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each melanoma asset appears in exactly one row. The 582 trials still recruiting or running carry 40% of the 1,463 registered trials in scope.

Which approved melanoma medicines are still in trials?

5 medicines already on the market are still being tested in melanoma Phase IV trials; Ipilimumab has the most, with 170 registered trials.

MedicineLead sponsorRegistered trials
IpilimumabSeveral sponsors170
TrametinibNovartis Pharmaceuticals45
DabrafenibNovartis Pharmaceuticals38
OpdualagSeveral sponsors22
TunlametinibShanghai Kechow Pharma, Inc.4

Post-approval melanoma trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many melanoma trials are recruiting patients now?

286 melanoma trials are recruiting patients and 63 more have not started recruiting yet, out of 1,463 interventional trials in scope; together they make up 24% of the trial base.

Registry statusTrialsShare
Completed48333%
Recruiting28620%
Terminated24517%
Active, not recruiting22916%
Status not verified1037.0%
Not yet recruiting634.3%
Withdrawn402.7%
Suspended100.7%
Enrolling by invitation40.3%

Terminated, suspended and withdrawn melanoma trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the melanoma pipeline?

Modulation Therapeutics, Inc. leads the melanoma pipeline with 12 candidates; the top 5 sponsors hold 12% of the 401 assets, and 190 sponsors run at least one.

SponsorAssets in developmentShare
Modulation Therapeutics, Inc.123.0%
Merck Sharp & Dohme LLC123.0%
Bristol-Myers Squibb92.2%
Novartis Pharmaceuticals92.2%
Hoffmann-La Roche82.0%

Industry sponsors lead 671 of the 1,463 melanoma trials (46%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the melanoma pipeline?

Mechanism and drug-type classification for the 401 melanoma candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What melanoma trial readouts are coming next?

35 melanoma candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

CandidateSponsorPhasePrimary completionRegistry
VV1Vyriad, Inc.Phase IIOct 2026 (estimated)NCT04291105
CemiplimabRegeneron PharmaceuticalsPhase IIOct 2026 (estimated)NCT04291105
EncorafenibPfizerPhase IIIOct 2026 (estimated)NCT04657991

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many melanoma readouts fall in each quarter?

74 melanoma candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 20, due in Q4 2027.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 20263811
Q1 202721012
Q2 2027358
Q3 2027224
Q4 202731720
Q1 2028415
Q2 2028055
Q3 2028099

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most melanoma trials?

United States hosts the most melanoma trials, with sites in 944 of the 1,463 studies (65%); trials in scope run in 67 countries in all.

CountryTrials with a siteShare of trials
United States94465%
Spain20314%
Australia19713%
France19413%
Canada15911%
Italy14710%
United Kingdom14610.0%
China1399.5%

A multinational melanoma trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are melanoma drugs being tested?

944 of the 1,463 melanoma trials (65%) have a site in the United States, 457 (31%) in Europe and 139 (9.5%) in China; 311 of the 401 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States94465%311FDA
Europe (EU/EEA, UK, Switzerland)45731%202EMA, MHRA, Swissmedic
China1399.5%85NMPA
Japan503.4%49PMDA
Rest of world37626%203national regulators

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational melanoma trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the melanoma pipeline since the last update?

This is the first edition of the melanoma pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the melanoma pipeline?

Douglas Insights read 1,463 interventional trials registered on ClinicalTrials.gov for the conditions "melanoma" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 401 unique candidates.

  1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
  2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
  3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
  4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

What does the Melanoma Pipeline Review include?

The Melanoma Pipeline Review covers all 401 candidates in an Excel tracker and profiles the leading 25 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.

11 chapters40–50 pages25 asset profilesExcel tracker of all 401 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where melanoma treatment is heading.

  • Pipeline size and phase mix
  • The three calls that matter
  • What changed since the last edition
02Disease and unmet need3 pp

Who is treated today, what current therapy leaves unmet, and how regulators judge new medicines.

  • Patient population and diagnosis
  • Treatment guidelines and gaps
  • Regulatory endpoints
03Approved therapies3 pp

The marketed medicines every melanoma candidate will be measured against.

  • Marketed medicines and their sponsors
  • Post-approval trials
  • The bar a new entrant must clear
04Pipeline at a glance4 pp

Every candidate counted by phase, drug type, sponsor and country.

  • Assets by phase and drug type
  • Sponsors by size of pipeline
  • Trial footprint: US, Europe, China, Japan
05Mechanism landscape and white space5 pp

Which mechanisms are crowded and which no sponsor has entered.

  • Mechanism classes and crowding
  • Classes with no candidate yet
  • Differentiation by route and dosing
06Key asset profiles12–15 pp

The leading 25 candidates, one profile each, every claim linked to a source document.

  • Design and endpoints of the pivotal trials
  • Data to date, with sources
  • Next readout and the risk to it
07Catalyst calendar3 pp

Readouts, filings and regulatory decisions 24 months ahead.

  • Readouts by quarter
  • Filings and regulatory decisions
  • Date confidence for each event
08Deals and partnering3 pp

Who is licensing, buying and partnering in melanoma, and on what terms.

  • Licensing and M&A in the area
  • Deal terms where disclosed
  • Sponsors open to partnering
09Sponsor landscape3 pp

Large pharma against biotech, and how concentrated the pipeline is.

  • Pipeline share by sponsor
  • Sponsor-by-phase matrix
  • New entrants since the last edition
10Our call: winners, risks, opportunities3–4 pp

The candidates most likely to win, ranked, with the reasoning and evidence.

  • Ranked candidates
  • Risks that could change the order
  • Openings for new entrants and investors
11Methodology and source log2 pp

How the count is built and every document behind it.

  • How candidates are counted and merged
  • Every source document listed
  • The ten quality checks

Ways to buy the Melanoma review

OptionWhat you getDeliveryPrice
Pipeline SnapshotThis therapy area as published: PDF report + Excel trackerReady nowUSD 3,000Enquire
Pipeline ReviewYour indication, geography and phase cut-off; ranked calls and an analyst call2–3 weeksFrom USD 4,000Enquire
Company AssessmentOne sponsor's full pipeline against its peers2 weeksFrom USD 5,000Enquire

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Frequently asked questions about the melanoma pipeline

How many drugs are in the melanoma pipeline?

401 drug candidates are in active clinical development for melanoma, with 42 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most melanoma drugs in development?

12 candidates make Modulation Therapeutics, Inc. the largest melanoma pipeline sponsor, out of 190 sponsors counted by Douglas Insights.

When is the next melanoma trial readout?

Oct 2026 is the registered primary completion of the Phase II trial of VV1 (NCT04291105), the next melanoma catalyst in Douglas Insights' calendar.

How many melanoma trials run in the United States and Europe?

944 melanoma trials have a US site and 457 a European site, out of 1,463 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the melanoma pipeline count updated?

90 days is the refresh cycle; this edition uses registry data as of 3 Oct 2026 and the next is due by 1 Jan 2027.

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

Cite this page Douglas Insights (2026). Melanoma Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/melanoma/