Oncology · In Clinical Trials
Plitidepsin (Aplidin)
No lawful US pathway
01 · Overview
Plitidepsin is a cyclic depsipeptide originally isolated from the Mediterranean tunicate Aplidium albicans. It binds the translation elongation factor eEF1A2, which appears to be its primary anticancer target (PMID 27713531).
In cancer cells it triggers oxidative stress and endoplasmic reticulum stress while blocking autophagy, leading to proteotoxic apoptosis (PMID 31812675). This mechanism differs from those of conventional anti-myeloma agents.
02 · Research summary & key findings
In the randomized phase 3 ADMYRE trial in relapsed or refractory multiple myeloma, plitidepsin plus dexamethasone improved progression-free survival compared with dexamethasone alone (median 2.6 vs 1.7 months by independent review), but overall survival was not significantly different in the intention-to-treat analysis (PMID 31240472). Plitidepsin was approved in Australia for multiple myeloma (PMID 32406881) but has not received FDA approval. A phase 3 COVID-19 trial was stopped early and showed only a non-significant trend toward faster oxygen withdrawal (PMID 39182994).
03 · Regulatory status
Plitidepsin (Aplidin) is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.
No lawful pathway today
Plitidepsin (Aplidin) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding.
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04 · Administration routes
- Intravenous
References
- [1]Translation Elongation Factor eEF1A2 is a Novel Anticancer Target for the Marine Natural Product Plitidepsin Sci Rep, 2016. PMID 27713531
- [2]Randomized phase III study (ADMYRE) of plitidepsin in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma Ann Hematol, 2019. PMID 31240472
- [3]Generation of endoplasmic reticulum stress and inhibition of autophagy by plitidepsin induces proteotoxic apoptosis in cancer cells Biochem Pharmacol, 2020. PMID 31812675
- [4]Plitidepsin to treat multiple myeloma Drugs Today (Barc), 2020. PMID 32406881
- [5]A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19 Clin Infect Dis, 2024. PMID 39182994
Primary literature
- PubMed: "Plitidepsin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Plitidepsin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Plitidepsin"
Chemical structure, molecular properties, and bioactivity data.
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