At a glance
- Plitidepsin is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 172 publications mentioning it, including 6 randomized controlled trials and 15 animal-only studies.
- ClinicalTrials.gov lists 16 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 16 reports mentioning it; 14 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- SARS-CoV-2 nucleocapsid protein hijacks host transcription by targeting eEF1A1.
- Plitidepsin induces apoptosis in glioma cells through β-TrCP-mediated ubiquitination and degradation of BMI1.
- Extending the Targets for Coronavirus Antivirals Beyond That of Approved Drugs: Insights From Preclinical Research.
- Comprehensive investigation of SARS-CoV-2 intestinal pathogenesis in Drosophila.
- Marine-Derived Anticancer Compounds and their Clinical Status.
- Exploring marine-derived compounds as potential anti-cancer agents: Mechanisms and therapeutic implications.
- Plitidepsin in combination with dexamethasone (ADMYRE trial) versus an external control arm of pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma.
- Can plitidepsin be used as an antiviral against RSV?
- Randomized Phase III Study (ADMYRE) of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Relapsed/Refractory Multiple Myeloma: Results for Patients Aged <75 Years.
- Pharmacological reprogramming of plitidepsin as a SARS-CoV-2 inhibitor.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 16
- Active
- 0
- With posted results
- 14
Conditions studied
Show 6 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| Aplidin - Dexamethasone in Relapsed/Refractory Myeloma | Completed | Phase 3 | Jun 2010 |
| Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas | Completed | Phase 1 | Dec 2008 |
| Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia | Terminated | Phase 1, Phase 2 | Nov 2007 |
| A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma | Completed | Phase 2 | Feb 2005 |
| A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer | Terminated | Phase 2 | Feb 2005 |
| Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma | Completed | Phase 2 | Dec 2004 |
All 16 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 16
- Serious
- 14
- With death outcome
- 1
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.