Drugs / Plitidepsin
Plitidepsin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Aplidin® | plasma cell myeloma | 2016-09-22 | “於今日向歐洲藥品管理局申請上市許可。” com.tw ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04382066 | May → Nov 2020 | COVID-19 | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT02100657 | Jun 2014 → Jun 2018 | plasma cell myeloma | PharmaMar | Completed | No outcome recorded |
| Phase 1 | NCT00788099 | Dec 2008 → Jun 2011 | cancer, lymphoma | PharmaMar | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05121740 | Jan → Mar 2022 | COVID-19 | PharmaMar | Completed | No outcome recorded |
| Phase 1/2 | NCT00780143 | Nov 2007 → Jun 2009 | leukemia | PharmaMar | Terminated | No outcome recorded Stop: Enrollment |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT06766825 | Feb 2025 → Sep 2026 | long COVID-19 | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 2 | NCT05705167 | Apr 2023 → Mar 2024 | COVID-19 | PharmaMar | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03117361 | May 2017 → Jul 2018 | plasma cell myeloma | PharmaMar | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03070964 | Oct 2016 → Jul 2018 | lymphoma | PharmaMar | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01876043 | Feb 2012 → Apr 2015 | dedifferentiated liposarcoma | Institut Bergonié | Terminated | Missed primary |
| Phase 2 | NCT01149681 | Jul 2010 → Feb 2011 | myelofibrosis | PharmaMar | Completed | No outcome recorded |
| Phase 2 | NCT00229203 | Feb 2005 → Aug 2008 | plasma cell myeloma | PharmaMar | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT04784559 | Jun 2021 → Mar 2023 | COVID-19 | PharmaMar | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT01102426 | Jun 2010 → Nov 2017 | refractory plasma cell neoplasm | PharmaMar | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-07-08 | PharmaMar | Regulatory Aplidin® will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar’s Marketing Authorization for Multiple Myeloma due to a conflict of interestAplidin® will be re-evaluated by the EMA. pharmamar.com ↗
The EC requests the European Medicines Agency, EMA, to re-evaluate the application for Aplidin in Multiple Myeloma. |
| 2022-01-11 | PharmaMar | Results Life Science Alliance journal publishes results of plitidepsin in patients with COVID-19, which includes additional data on its antiviral activity against Delta and Omicron variants pharmamar.com ↗
According to the final data published in this article, plitidepsin has been shown to have a potent antiviral activity in all variants at very low (nanomolar) concentrations, with a positive in vitro therapeutic index. |
| 2021-05-26 | PharmaMar | Results PharmaMar announces results of its APLICOVPC study in adult patients with COVID-19 requiring hospital admission pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today the final results of its APLICOV-PC clinical trial with Aplidin® (plitidepsin) for the treatment of adult patients with COVID-19 requiring hospitalization, which met the primary safety endpoint and showed clinical efficacy. |
| 2021-04-29 | PharmaMar | Regulatory PharmaMar receives authorization to initiate the Phase III NEPTUNO clinical trial with plitidepsin for the treatment of COVID-19 pharmamar.com ↗
This authorization has been obtained through the European Union’s Voluntary Harmonization Procedure (VHP) for clinical trials. |
| 2021-02-17 | PharmaMar | Regulatory UK approves the initiation of the Phase III NEPTUNO clinical trial with PharmaMar’s Aplidin® (plitidepsin) for the treatment of patients with COVID-19 pharmamar.com ↗
PharmaMar (MSE:PHM) has announced today that it has obtained Medicines and Healthcare products Regulatory Agency (MHRA) approval for UK patients to participate in the Phase III NEPTUNO clinical trial, which will determine the efficacy of Aplidin® (plitidepsin) for the treatment of hospitalized patients with moderate COVID-19 infection. |
| 2021-01-26 | PharmaMar | Results The Peer Review journal Science confirms the potent activity of PharmaMar’s plitidepsin against SARS-CoV-2 pharmamar.com ↗
Here, in two different animal models of SARS-CoV-2 infection, the trial demonstrated reduction of viral replication, resulting in a 99% reduction of viral loads in the lung of plitidepsin-treated animals. |
| 2020-10-30 | TTY Biopharm | Results 東洋代理之歐洲原廠藥Plitidepsin傳來好消息 com.tw ↗
日前，PharmaMar公司公布第一/二期的人體臨床試驗結果，Plitidepsin達到安全性的主要試驗目標和療效次要試驗目標，以及顯著減少住院患者的病毒量和C反應蛋白（CRP）。 |
| 2016-09-22 | TTY Biopharm | Regulatory 台灣東洋在台獨家經銷代理癌症新成分新藥Aplidin 今日向歐洲藥品管理局申請上市許可 com.tw ↗
台灣東洋藥品(4105：TW)今日與合作夥伴PharmaMar公司共同宣布，PharmaMar公司開發之新成分新藥Plitidepsin(商品名：Aplidin®)，繼其第三期臨床試驗ADMYRE的結果符合臨床試驗設計目標結果，即對復發或是多線治療失敗的多發性骨髓瘤患者併用Aplidin®與Dexamethason(類固醇)比上單獨使用Dexamethason，證實有使用Aplidin的病患可以明顯降低35%疾病惡化或是死亡風險後，於今日向歐洲藥品管理局申請上市許可。 |
| 2016-03-31 | TTY Biopharm | Results 台灣東洋在台獨家經銷代理癌症全新藥品Aplidin多發性骨髓瘤III期臨床試驗成果達標 com.tw ↗
證實有使用Aplidin的病患可以明顯降低35%疾病惡化或是死亡風險, 具有統計學顯著差異(p=0.0054)，已經達到該研究臨床主要目標(primary end point)。 |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Plitidepsin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05705167 ↗ |
| Known as | Aplidin | “Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide” NCT03117361 ↗3“Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia” NCT00780143 ↗ “Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma” NCT02100657 ↗ “Drug: APLIDIN (plitidepsin)” NCT01149681 ↗ |
| Known as | APLIDIN (plitidepsin) | “APLIDIN (plitidepsin)” NCT01102426 ↗ |
| Action | Inhibit | “Plitidepsin, a marine-derived cyclic-peptide, inhibits SARS-CoV-2 replication at nanomolar concentrations by targeting the host protein eukaryotic translation elongation factor 1A.” PMID 35012962 ↗ Jan 2022 |
| Modality | Peptide | “Plitidepsin, a marine-derived cyclic-peptide, inhibits SARS-CoV-2 replication at nanomolar concentrations by targeting the host protein eukaryotic translation elongation factor 1A.” PMID 35012962 ↗ Jan 2022 |
| Route | Intravenous | “Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks” NCT00229203 ↗ |