Iloprost

Overview

Iloprost is a synthetic analogue of prostacyclin PGI2 that dilates systemic and pulmonary arterial vascular beds. It is used to treat pulmonary arterial hypertension (PAH).

Indication

Used for the treatment of pulmonary arterial hypertension.

Associated Conditions

NYHA class III Pulmonary arterial hypertension
NYHA class IV Pulmonary arterial hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure	2024/03/20	NCT06319274	Phase 2	Recruiting	Pär Johansson
Oral Iloprost for the Prevention of Lung Cancer In Former Smokers	2022/06/09	NCT05411107	Phase 2	Withdrawn	National Cancer Institute (NCI)
Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery	2020/10/22	NCT04598191	Not Applicable	UNKNOWN	Yonsei University
Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation	2020/10/12	NCT04583046	Not Applicable	UNKNOWN	Yonsei University
A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture	2020/09/10	NCT04543682	Phase 1	Recruiting	Charite University, Berlin, Germany
Inhaled Iloprost for Suspected COVID-19 Respiratory Failure	2020/06/24	NCT04445246	Phase 2	Completed	Hamad Medical Corporation
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure	2020/06/09	NCT04420741	Phase 2	Completed	Pär Johansson
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure	2019/10/11	NCT04123444	Phase 2	Completed	Jakob Stensballe, MD, PhD
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)	2019/07/31	NCT04040322	Phase 3	Completed	Civi Biopharma, Inc.
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery	2019/05/03	NCT03936140	Not Applicable	Completed	Seoul St. Mary's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
VENTAVIS	Actelion Pharmaceuticals US, Inc.	66215-303	RESPIRATORY (INHALATION)	20 ug in 1 mL	3/9/2022
VENTAVIS	Actelion Pharmaceuticals US, Inc.	66215-302	RESPIRATORY (INHALATION)	10 ug in 1 mL	3/9/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Ventavis	Bayer AG,Kaiser-Wilhelm-Allee 1,51373 Leverkusen,Germany	Authorised	9/15/2003

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VENTAVIS SOLUTION FOR INHALATION	BERLIMED SA	SIN13140P	SOLUTION	0.010 mg/ml	7/6/2005

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
VENTAVIS iloprost 10 microgram/mL solution for inhalation ampoule	97219	Bayer Australia Ltd	Medicine	A	1/21/2004

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ILOPROST TEVA 20 MICROGRAMOS/ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Teva B.V.	84421	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
ILOPROST TEVA 50 MICROGRAMOS/0,5 ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFG	Teva B.V.	84422	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
ILOPROST RAFARM 10 MICROGRAMOS/ML SOLUCION PARA INHALACION POR NEBULIZADOR	Rafarm S.A.	86242	SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR	Uso Hospitalario	Commercialized
ILOMEDIN 50 MICROGRAMOS/0,5 ML, CONCENTRADO PARA SOLUCION PARA PERFUSION	Bayer Hispania S.L.	61596	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
ILOPROST ZENTIVA 20 MICROGRAMOS/ML SOLUCION PARA INHALACION POR NEBULIZADOR	Zentiva K.S.	86227	SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR	Uso Hospitalario	Commercialized
ILOPROST ZENTIVA 10 MICROGRAMOS/ML SOLUCION PARA INHALACION POR NEBULIZADOR	Zentiva K.S.	86226	SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR	Uso Hospitalario	Commercialized

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.

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