Papaverine

Overview

An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. It is a direct-acting smooth muscle relaxant used in the treatment of impotence and as a vasodilator, especially for cerebral vasodilation. The mechanism of its pharmacological actions is not clear, but it apparently can inhibit phosphodiesterases and it may have direct actions on calcium channels.

Indication

For the treatment of impotence and vasospasms.

Associated Conditions

Vascular spasm
Visceral spasms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial	2025/02/19	NCT06834126	Phase 1	Recruiting	City of Hope Medical Center
IV PAPAVERINE Prior to Propess for Labor Induction	2024/08/12	NCT06550232	Phase 4	Completed	Western Galilee Hospital-Nahariya
Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction	2024/08/09	NCT06547437	Not Applicable	Not yet recruiting	Western Galilee Hospital-Nahariya
The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography	2023/05/17	NCT05861765	Phase 2	Recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer	2021/11/29	NCT05136846	Phase 1	Recruiting	Ohio State University Comprehensive Cancer Center
Effect of Papaverine on Renal Artery Blood Flow Volume	2019/11/14	NCT04162834	Phase 4	Completed	Asan Medical Center
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter	2019/07/24	NCT04030663	Early Phase 1	Completed	Kasr El Aini Hospital
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients	2019/03/29	NCT03894904	Phase 4	Completed	The University of Texas Health Science Center, Houston
Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases	2019/01/31	NCT03824327	Phase 1	Recruiting	Ohio State University Comprehensive Cancer Center
Prostatic Hyperplasia Treatment and Cancer Prevention	2017/02/27	NCT03064282	Early Phase 1	UNKNOWN	Manchanda Medical Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PAPAVERINE HYDROCHLORIDE	BPI Labs LLC	54288-142	PARENTERAL, INTRAVENOUS, INTRAMUSCULAR	30 mg in 1 mL	4/26/2023
Papaverine Hydrochloride	American Regent, Inc.	0517-4002	INTRAVENOUS	30 mg in 1 mL	11/17/2023
Papaverine Hydrochloride	Oryza Pharmaceuticals Inc.	72516-024	INTRAVENOUS	30 mg in 1 mL	1/26/2021
Papaverine Hydrochloride	Nexus Pharamaceuticals Inc.	14789-121	INTRAVENOUS, INTRAMUSCULAR	30 mg in 1 mL	5/1/2023

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
UNI-CODPLEX SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	12/14/1998
DIPHETAN COUGH SYRUP	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	8/20/1986
CODOLAX COMPLEX SYRUP	N/A	VICKMANS LABORATORIES LIMITED	N/A	N/A	5/25/1979
NEW CO-FINE COUGH SYRUP	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	2/23/2001
STOP COUGH MIXTURE	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	1/28/2010
BROMHEXINE CO ELIXIR	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/25/1983
NEO CODO COUGH SYRUP	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	8/25/1998
P-COUGH SYRUP	N/A	JEAN-MARIE PHARMACAL COMPANY LIMITED	N/A	N/A	2/13/1989
COPAMINE SYRUP	N/A	JEAN-MARIE PHARMACAL COMPANY LIMITED	N/A	N/A	10/3/1998
COPALIN TAB	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	9/25/2000

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DBL PAPAVERINE HYDROCHLORIDE 120mg/10mL Injection	16277	Pfizer Australia Pty Ltd	Medicine	A	10/8/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PAPAVERINUM-INJEEL LIQ	Biologische Heilmittel Heel Gmbh	02073226	Liquid - Oral	12 D / 1.1 ML	12/31/1994
PAPAVERINUM-INJEEL LIQ	Biologische Heilmittel Heel Gmbh	02073226	Liquid - Oral	200 D / 1.1 ML	12/31/1994
PAPAVERINUM-INJEEL LIQ	Biologische Heilmittel Heel Gmbh	02073226	Liquid - Oral	30 D / 1.1 ML	12/31/1994
PAPAVERINUM-INJEEL FORTE LIQ (4D,12D,30D,200D/1.1ML)	Biologische Heilmittel Heel Gmbh	02073234	Liquid - Oral	4 D / 1.1 ML	12/31/1994
PAPAVERINE HYDROCHLORIDE INJECTION USP	Sandoz Canada, Inc.	00009881	Liquid - Intravenous , Subcutaneous , Intramuscular	65 MG / 2 ML	12/31/1951

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.

Related News

City of Hope Launches DINOMITE Trial Testing Papaverine to Enhance Radiation Therapy in Rectal Cancer

4 months ago

City of Hope has opened a phase 1 clinical trial called DINOMITE to test papaverine, an investigational drug that sensitizes tumor cells to radiation therapy by blocking oxygen consumption in cancer cells.

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