Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Melanoma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Melanoma. ClinicalTrials.gov lists 1 registered trial linking Indomethacin to Melanoma: 1 has completed. The most advanced is Phase 2 (NCT00002535). Registered activity dates to 1993. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1989 to 2020. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Melanoma ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression documented in ~0.4% of metastatic melanoma cases; early-stage surgical resection: 90%+ 5-year survival for Stage I; Stage IV (metastatic): historically <10% 5-year survival.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 41.5 (trials 3.5, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00002535 | Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma 1993 | completed | Phase 2 | — |
Published literature
- Cochrane review The association between nonsteroidal anti-inflammatory drugs and skin cancer: Different responses in American and European populationsMa Y, Yu P, Lin S et al. · Pharmacological research · 2020 · PMID 31689521
- Clinical trial publication Effect of T-activin therapy on indomethacin modulation of lymphoproliferative response in vitro of melanoma patientsStanojević-Bakić N, Vucković-Dekić L, Milosević D et al. · Panminerva medica · 1998 · PMID 9973828
- Clinical trial publication Phase II trial of interleukin 1 alpha and indomethacin in treatment of metastatic melanomaJanik JE, Miller LL, Longo DL et al. · Journal of the National Cancer Institute · 1996 · PMID 8847725
- Clinical trial publication Oral indomethacin and ranitidine in advanced melanoma: a phase II studyMertens WC, Lohmann RC · Clinical oncology (Royal College of Radiologists (Great Britain)) · 1996 · PMID 8859609
- Clinical trial publication Utility of 111In-labelled leukocytes in patients completing high-dose interleukin-2 therapy: a pilot studyMertens WC, Power JE · Nuclear medicine communications · 1994 · PMID 8170641
- Clinical trial publication Sustained indomethacin and ranitidine with intermittent continuous infusion interleukin-2 in advanced malignant melanoma: a phase II studyMertens WC, Bramwell VH, Banerjee D et al. · Clinical oncology (Royal College of Radiologists (Great Britain)) · 1993 · PMID 8481359
- Randomized controlled trial Randomized trial of recombinant alpha 2b-interferon with or without indomethacin in patients with metastatic malignant melanomaMiller RL, Steis RG, Clark JW et al. · Cancer research · 1989 · PMID 2647294
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Melanoma?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Melanoma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Melanoma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Melanoma?
ClinicalTrials.gov lists 1 registered trial linking Indomethacin to Melanoma: 1 has completed. The most advanced is Phase 2 (NCT00002535). Registered activity dates to 1993.
What does the evidence show for Indomethacin in Melanoma?
Indomethacin has both completed registered trials and synthesis-level publications linked to Melanoma. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.