Alprostadil

Overview

Alprostadil is a chemically-identical synthetic form of prostaglandin E1 (PGE1), a potent vasodilator produced endogenously. In 1996, the FDA approved the use of alprostadil, administered either with an intracavernosal injection or an intraurethral suppository, for the treatment of erectile dysfunction, and it is used in men for whom oral treatment is either contraindicated or ineffective. After administration, alprostadil promotes smooth muscle relaxation of the corpus cavernosal. Alprostadil is also used in neonatal patients with congenital heart defects that depend on a patent ductus for survival until corrective or palliative surgery can be performed. This drug causes vasodilation by directly affecting vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This results in increased pulmonary or systemic blood flow in infants.

Indication

Alprostadil is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. It is also indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology, and as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Associated Conditions

Erectile Dysfunction
Patent Ductus Arteriosus (PDA)
Raynaud's Phenomenon

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)	2025/01/10	NCT06768177	Not Applicable	ENROLLING_BY_INVITATION	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
A Study to Explore the Efficacy of Alprostadil Liposomes Injection in the Prevention of CI-AKI	2022/07/27	NCT05475717	Phase 2	Terminated	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns	2020/08/03	NCT04496050	N/A	UNKNOWN	Hacettepe University
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.	2020/03/18	NCT04312555	Phase 4	UNKNOWN	Assiut University
Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran	2019/12/13	NCT04197323	Phase 2	UNKNOWN	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow	2019/08/13	NCT04054115	Phase 1	Terminated	The Hospital for Sick Children
The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury	2019/03/27	NCT03892447	Phase 4	UNKNOWN	Shengjing Hospital
Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy	2019/02/22	NCT03851562	Phase 2	UNKNOWN	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Evaluation of Nail Fold Microcirculation in CKD	2018/09/25	NCT03682952	Phase 4	UNKNOWN	The Affiliated Hospital of Xuzhou Medical University
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers	2018/09/13	NCT03669562	Phase 1	UNKNOWN	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
MUSE	Meda Pharmaceuticals Inc.	0037-8120	URETHRAL	250 ug in 1 1	4/25/2018
Edex	Endo Pharmaceuticals Inc.	52244-040	INTRACAVERNOUS	40 ug in 1 mL	7/11/2022
Caverject	Pharmacia & Upjohn Company LLC	0009-7686	INTRACAVERNOUS	41.1 ug in 1 mL	3/1/2023
MUSE	Meda Pharmaceuticals Inc.	0037-8110	URETHRAL	125 ug in 1 1	4/25/2018
PROSTIN VR PEDIATRIC	Pharmacia & Upjohn Company LLC	0009-0215	INTRAVENOUS, INTRAVASCULAR	500 ug in 1 mL	10/3/2022
Caverject	Pharmacia & Upjohn Company LLC	0009-3701	INTRACAVERNOUS	20.5 ug in 1 mL	3/1/2023
MUSE	Meda Pharmaceuticals Inc.	0037-8140	URETHRAL	1000 ug in 1 1	4/25/2018
Caverject Impulse	U.S. Pharmaceuticals	63539-121	INTRACAVERNOUS	10 ug in 0.5 mL	10/1/2016
Caverject Impulse	U.S. Pharmaceuticals	63539-221	INTRACAVERNOUS	20 ug in 0.5 mL	10/1/2016
PROSTIN VR PEDIATRIC	Pharmacia and Upjohn Company LLC	0009-3169	INTRAVENOUS, INTRAVASCULAR	500 ug in 1 mL	5/8/2020

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
CAVERJECT POWDER FOR INJECTION 20 mcg/ml	PFIZER MANUFACTURING BELGIUM NV	SIN08097P	INJECTION, POWDER, FOR SOLUTION	20 mcg/ml	3/28/1995
PROSTIN VR PAEDIATRIC INJECTION 0.5 mg/ml	PHARMACIA & UPJOHN CO	SIN02280P	INJECTION	0.5 mg/ml	7/14/1988

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
Prostin VR 500 microgram/1mL injection ampoule	47641	Pfizer Australia Pty Ltd	Medicine	A	4/11/1994
CAVERJECT IMPULSE alprostadil 20microgram powder for injection with 0.5mL diluent dual chamber cartridge in single use syringe device	90197	Pfizer Australia Pty Ltd	Medicine	A	7/29/2002
NEUPEDIX alprostadil 500 microgram/1 mL solution for injection ampoule	446011	Waymade Australia Pty Limited	Medicine	A	5/9/2025
CAVERJECT IMPULSE alprostadil 10microgram powder for injection with 0.5mL diluent dual chamber cartridge in single use syringe device	90196	Pfizer Australia Pty Ltd	Medicine	A	7/29/2002

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CAVERJECT STERILE POWDER - PWS 23.2MCG/VIAL	Pfizer Canada Ulc	02215187	Powder For Solution - Intracavernosal	20 MCG / VIAL	9/24/1997
ALPROSTADIL INJECTION, USP	novopharm limited	02241680	Liquid - Intravenous , Intra-Arterial	500 MCG / ML	10/26/2000
CAVERJECT STERILE POWDER	Pfizer Canada Ulc	02215756	Powder For Solution , Liquid , Kit - Intracavernosal	20 MCG / VIAL	8/29/1997
CAVERJECT STERILE POWDER - KIT 11.9MCG /VIAL	Pfizer Canada Ulc	02215748	Liquid , Powder For Solution , Kit - Intracavernosal	11.9 MCG / VIAL	7/30/1996
MUSE	Endo Operations Ltd.	02238593	Suppository - Urethral	250 MCG	9/24/1998
MUSE	Endo Operations Ltd.	02238595	Suppository - Urethral	1000 MCG	9/24/1998
CAVERJECT STERILE POWDER - PWS 11.9MCG/VIAL	Pfizer Canada Ulc	02215179	Powder For Solution - Intracavernosal	11.9 MCG / VIAL	7/30/1996
PROSTIN VR STERILE SOLUTION	Pfizer Canada Ulc	00559253	Solution - Intra-Arterial , Intravenous	500 MCG / ML	12/31/1982
MUSE	paladin pharma inc.	02238592	Suppository - Urethral	125 MCG	N/A
VITAROS	BGP Pharma ULC	02359421	Cream - Topical	330 MCG / 100 MG	N/A

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