Plitidepsin

Overview

Aplidine is a peptide found in tunicates which shows promise in shrinking tumors in pancreatic, stomach, bladder, and prostate cancers. The specific marine organism is Aplidium albicans. Aplidine is also of interest as a potential treatment for some leukemias.

Indication

Intended for the treatment of various forms of cancer.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC)	2025/01/09	NCT06766825	Phase 2	Recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA)	2023/01/30	NCT05705167	Phase 2	Terminated	PharmaMar
Extension Study in a Cohort of Adult Patients With COVID-19 Infection	2021/11/16	NCT05121740	Phase 1	Completed	PharmaMar
Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection	2021/03/05	NCT04784559	Phase 3	Terminated	PharmaMar
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19	2020/05/11	NCT04382066	Phase 1	Completed	PharmaMar
Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide	2017/04/17	NCT03117361	Phase 2	Terminated	PharmaMar
A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma	2017/03/06	NCT03070964	Phase 2	Terminated	PharmaMar
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma	2014/04/01	NCT02100657	Phase 1	Completed	PharmaMar
Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial	2013/06/12	NCT01876043	Phase 2	Terminated	Institut Bergonié
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma	2010/04/13	NCT01102426	Phase 3	Completed	PharmaMar

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
APLIDIN plitidepsin 2 mg powder for solution for infusion; vial (2 mg powder) and ampoule (4 mL solution)	291661	Specialised Therapeutics Pharma Pty Ltd	Medicine	A	12/12/2018

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