Pentamidine

Overview

Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of pneumocystis pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.

Indication

For the treatment of pneumonia due to Pneumocystis carinii.

Associated Conditions

Pneumocystis Jirovecii Pneumonia
Trypanosomiasis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pentamidine + Salvage Chemo for Relapsed/Refractory Classical Hodgkin Lymphoma	2018/11/05	NCT03730363	Phase 1	Completed	Reinhold Munker
Hypertrophic Scar Prevention by Novel Topical Gel Application	2018/01/18	NCT03403621	Phase 1	Terminated	Mayo Clinic
A Pilot, Dose Escalating Study on VLX103 in Moderate Alcoholic Steatohepatitis	2017/06/28	NCT03201159	Phase 1	Withdrawn	Gyongyi Szabo
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia	2017/03/30	NCT03096457	Phase 2	Completed	Fundacion Nacional de Dermatologia
Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia	2016/02/01	NCT02669706	N/A	Completed	University of Illinois at Chicago
A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma	2014/08/06	NCT02210182	Phase 1	Completed	Oncozyme Pharma Inc.
Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study	2011/05/26	NCT01360762	Phase 3	Completed	Institute of Tropical Medicine, Belgium
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy	2008/12/18	NCT00810953	Phase 1	Completed	Oncozyme Pharma Inc.
A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment	2008/12/17	NCT00809796	Phase 1	Completed	Oncozyme Pharma Inc.
Trial of DB289 for the Treatment of Stage I African Trypanosomiasis	2008/12/08	NCT00803933	Phase 2	Completed	Immtech Pharmaceuticals, Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pentamidine Isethionate	XGen Pharmaceuticals DJB, Inc.	39822-3030	RESPIRATORY (INHALATION)	300 mg in 6 mL	3/18/2024
Pentamidine Isethionate	Seton Pharmaceuticals	13925-515	INTRAMUSCULAR, INTRAVENOUS	300 mg in 300 mg	3/20/2018
NebuPent	Fresenius Kabi USA, LLC	63323-877	RESPIRATORY (INHALATION)	300 mg in 6 mL	1/23/2020
PENTAMIDINE ISETHIONATE	XGen Pharmaceuticals DJB, Inc.	39822-3050	INTRAVENOUS, INTRAMUSCULAR	300 mg in 3 mL	1/25/2024
Pentam 300	Fresenius Kabi USA, LLC	63323-113	INTRAMUSCULAR, INTRAVENOUS	300 mg in 3 mL	9/13/2022
pentamidine isethionate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-748	INTRAMUSCULAR, INTRAVENOUS	300 mg in 300 mg	4/1/2021
Pentamidine Isethionate	Seton Pharmaceuticals	13925-522	RESPIRATORY (INHALATION)	300 mg in 300 mg	10/11/2019

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
DBL PENTAMIDINE ISETHIONATE FOR INJECTION BP 300 mg/vial	HOSPIRA AUSTRALIA PTY LTD	SIN06766P	INJECTION, POWDER, FOR SOLUTION	300 mg/vial	1/13/1992

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
PENTACARINAT POWDER FOR INJ 300MG	N/A	main life corp ltd	N/A	N/A	2/19/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DBL PENTAMIDINE ISETHIONATE 300mg powder for injection	16260	Pfizer Australia Pty Ltd	Medicine	A	10/8/1991
Hospira Pentamidine Isetionate for Injection BP 300 mg/vial	142577	Hospira Australia Pty Ltd	Medicine	A	7/26/2007
Pentamina (Pentamidina) for Injection 300 mg vial	140692	Hospira Australia Pty Ltd	Medicine	A	6/20/2007
Hospira Pentamidine Isethionate for Injection BP, 300 mg/Vial	378671	Hospira Australia Pty Ltd	Medicine	A	11/23/2021
PENTAMIDINE-EMC pentamidine isetionate 300 mg powder for injection vial	338274	Emcure Pharmaceuticals Pty Ltd	Medicine	A	9/26/2023
Hospira Pentamidine Isethionate for Injection BP, 300 mg/Vial	377599	Hospira Australia Pty Ltd	Medicine	A	11/8/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PENTACARINAT 300 INJ PWS 300MG/VIAL	aventis pharma inc	01926748	Powder For Solution - Inhalation , Intramuscular , Intravenous	300 MG / VIAL	12/31/1989
PENTAMIDINE ISETIONATE FOR INJECTION BP	Pfizer Canada Ulc	02183080	Powder For Solution - Intramuscular , Intravenous	300 MG / VIAL	9/10/1998
PENTAMIDINE ISETIONATE FOR INJECTION BP	marcan pharmaceuticals inc	02517663	Powder For Solution - Intravenous , Intramuscular	300 MG / VIAL	10/14/2021
PENTAMIDINE ISETHIONATE INJ 300MG/VIAL BP	david bull laboratories (pty) ltd.	00886874	Powder For Solution - Intramuscular , Intravenous	300 MG / VIAL	12/31/1990

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access