Iloprost

also known as Ventavis · BAYQ6256 · Ilomedin · Aurlumyn · BAYQ6252 · Ciloprost · Endoprost · ZK 00036374 · +1 more

Other / unclassified targets PTGIR via activation

Developed for: pulmonary hypertension · pulmonary arterial hypertension · chronic obstructive pulmonary disease · lung cancer · acute respiratory distress syndrome · infectious disease with sepsis · congenital heart disease · COVID-19
+26 more
· lung carcinoma · type 2 diabetes mellitus · acute lung injury · acute respiratory failure · asthma · cardiac arrest · diastolic heart failure · Eisenmenger syndrome · idiopathic pulmonary fibrosis · left ventricular failure · multiple organ dysfunction syndrome · myocardial infarction · peripheral arterial disease · peripheral arterial occlusive disease 1 · pneumonia · precancerous condition · pulmonary hypertension owing to lung disease and/or hypoxia · Raynaud disease · respiratory failure · respiratory system disorder · sarcoidosis · sickle cell disease · systemic sclerosis · adult acute respiratory distress syndrome · chronic ulcer of skin · hypertensive disorder
Investigated by: Actelion · Bayer · Yonsei University · Pär Johansson · National Cancer Institute (NCI) · Duke University
+50 more
· Heidelberg University · Rigshospitalet, Denmark · Shanghai Jiao Tong University School of Medicine · Thrombologic ApS · University of Oklahoma · University of Sao Paulo General Hospital · Aalborg University Hospital · Aarhus University Hospital · Air Force Military Medical University, China · Algora · Amsterdam UMC, location VUmc · Anders Perner · Assistance Publique - Hôpitaux de Paris · Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery · Carmel Medical Center · Charite University, Berlin, Germany · Fadoi Foundation, Italy · Hamad Medical Corporation · Independent Research Fund Denmark · Innovation Fund Denmark · Interstitial Lung Disease Study Group, Korea · Jakob Stensballe, MD, PhD · Lene Holmvang · Loma Linda University · Louisiana State University Health Sciences Center in New Orleans · Ludwig-Maximilians - University of Munich · Lund University Hospital · National Center for Research Resources (NCRR) · National Taiwan University Hospital · Novotech (Australia) Pty Limited · Odense University Hospital · Onassis Cardiac Surgery Centre · Oslo University Hospital · Pharmosa Biopharm Inc. · Prim PD Dr Afshin Assadian · Seattle Children's Hospital · Seoul St. Mary's Hospital · Sisse R. Ostrowski, MD PhD DMSc · The Catholic University of Korea · University Hospital, Grenoble · University Hospital, Rouen · University of California, Los Angeles · University of Chicago · University of Cincinnati · University of Colorado, Denver · University of Giessen · University of Pittsburgh · VA Loma Linda Health Care System · Vanderbilt University · Wilhelminenspital Vienna

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	VENTAVIS	—	2005-08-24	fda.gov ↗
Approved	US (FDA)	VENTAVIS	—	2004-12-29	fda.gov ↗
Approved	EU (EMA)	Ventavis	—	2003-09-15	europa.eu ↗

Trials 66 · started per year

today

EU approved 2003

US approved 2004

199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT01209533	Sep 2010 → Jul 2011	asthma	Vanderbilt University	Completed	No outcome recorded
Phase 15 trials
Phase 1	NCT06429930	Apr 2025 → Jun 2026 overdue	pulmonary arterial hypertension	Pharmosa Biopharm Inc.	Recruiting	No outcome recorded
Phase 1	NCT02237183	Nov 2015 → Mar 2020	lung carcinoma	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 1	NCT01274481	Mar 2011 → Jul 2012	acute lung injury, acute respiratory distress syndrome, pulmonary hypertension	University of Oklahoma	Completed	No outcome recorded
Phase 1	NCT00724321	Jul → Nov 2008	—	Loma Linda University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1	NCT00708565	Jul → Oct 2008	pulmonary hypertension	VA Loma Linda Health Care System	Unknown	No outcome recorded
Phase 1/25 trials
Phase 1/2	NCT04543682	May 2022 → May 2024	—	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 1/2	NCT02032836	Mar 2014 → Jan 2015	pulmonary arterial hypertension	Bayer	Completed	No outcome recorded
Phase 1/2	NCT01179776	Sep 2010 → May 2011	myocardial infarction	Thrombologic ApS	Completed	No outcome recorded
Phase 1/2	NCT01082484	Jan 2010 → Jan 2011	—	University Hospital, Grenoble	Completed	No outcome recorded
Phase 1/2	NCT00981591	Sep 2009 → Mar 2013	acute respiratory distress syndrome, congenital heart disease, neonatal respiratory failure, pulmonary hypertension, neonatal	Seattle Children's Hospital	Withdrawn	No outcome recorded Stop: Enrollment
Phase 218 trials · 1 met primary · 2 missed
Phase 2	NCT05411107	Jun 2024 → Dec 2026	chronic obstructive pulmonary disease, lung carcinoma	National Cancer Institute (NCI)	Withdrawn	No outcome recorded
Phase 2	NCT06319274	Apr 2024 → Sep 2027 expected	acute respiratory failure, infectious disease	Pär Johansson	Recruiting	No outcome recorded
Phase 2	NCT04420741	Jun 2020 → Feb 2021	COVID-19, respiratory failure	Pär Johansson	Completed	No outcome recorded
Phase 2	NCT04445246	May 2020 → May 2021	COVID-19, acute respiratory distress syndrome	Hamad Medical Corporation	Completed	No outcome recorded
Phase 2	NCT03903939	May 2019 → Nov 2021	multiple organ dysfunction syndrome	Pär Johansson	Completed	No outcome recorded
Phase 2	NCT02685618	Feb → Aug 2016	cardiac arrest	Pär Johansson	Completed	Missed primary
Phase 2	NCT02482402	Feb → Mar 2015	left ventricular failure, pulmonary hypertension	Heidelberg University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT02204852	Sep 2014 → Aug 2016	infectious disease with sepsis	Sisse R. Ostrowski, MD PhD DMSc	Completed	Missed primary
Phase 2	NCT01941225	Sep 2013 → Nov 2016	chronic obstructive pulmonary disease	Louisiana State University Health Sciences Center in New Orleans	Completed	No outcome recorded
Phase 2	NCT01774058	Oct 2012 → Jun 2019	arteriosclerosis disorder, peripheral arterial occlusive disease 1, peripheral neuropathy, type 2 diabetes mellitus	Prim PD Dr Afshin Assadian	Unknown	No outcome recorded
Phase 2	NCT01532544	Jun 2012 → Mar 2014	pneumonia	Thrombologic ApS	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01437878	Mar → Nov 2012	chronic obstructive pulmonary disease, pulmonary hypertension	Actelion	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00467896	Sep 2006 → Nov 2010	pulmonary hypertension	Actelion	Terminated	Met primary
Phase 2	NCT00453414	Jul → Oct 2006	pulmonary arterial hypertension	Actelion	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT00109681	Apr 2005 → Oct 2006	idiopathic pulmonary fibrosis, pulmonary hypertension	Actelion	Completed	No outcome recorded
Phase 2	NCT00086463	Jun 2004 → Jan 2006	pulmonary arterial hypertension	Actelion	Completed	No outcome recorded
Phase 2	NCT00084409	Nov 2001 → Jan 2009	lung cancer, precancerous condition	University of Colorado, Denver	Completed	No outcome recorded
Phase 2	NCT00414687	Jul 1998 → May 2001	pulmonary hypertension	Bayer	Completed	No outcome recorded

Phase 2/34 trials · 1 met primary · 1 missed
Phase 2/3	NCT04123444	Oct 2019 → Jun 2022	infectious disease with sepsis	Jakob Stensballe, MD, PhD	Completed	Missed primary
Phase 2/3	NCT01310751	Jan 2011 → Dec 2013	pulmonary hypertension	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 2/3	NCT00439543	Mar → Aug 2007	pulmonary fibrosis, pulmonary hypertension	Interstitial Lung Disease Study Group, Korea	Unknown	No outcome recorded
Phase 2/3	NCT00345501	Nov 2005 → Jul 2007	chronic kidney disease	Onassis Cardiac Surgery Centre	Completed	Met primary
Phase 312 trials · 1 met primary · 3 missed
Phase 3	NCT07498309	Sep 2026 → Mar 2030 expected	sickle cell disease	University Hospital, Rouen	Not yet recruiting	No outcome recorded
Phase 3	NCT03788837	Jul 2019 → Jan 2024	infectious disease with sepsis	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT01712997	Sep 2012 → Sep 2014	pulmonary arterial hypertension	Air Force Military Medical University, China	Unknown	Met primary
Phase 3	NCT01469169	Jun 2012 → Dec 2014	pulmonary arterial hypertension	Bayer	Completed	No outcome recorded
Phase 3	NCT01598441	Jun 2012 → Nov 2016	pulmonary hypertension	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 3	NCT00927654	Jun 2009 → Mar 2012	pulmonary hypertension	Ludwig-Maximilians - University of Munich	Completed	Missed primary
Phase 3	NCT00709098	Sep 2008 → Jun 2010	pulmonary arterial hypertension	Actelion	Completed	No outcome recorded
Phase 3	NCT00709956	Jul 2008 → Aug 2009	pulmonary arterial hypertension	Actelion	Completed	Missed primary
Phase 3	NCT00723554	Jul 2008 → Aug 2010	pulmonary arterial hypertension	Actelion	Terminated	No outcome recorded
Phase 3	NCT00302211	Feb 2006 → Dec 2007	pulmonary hypertension	Actelion	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00185315	Feb 2000 → Aug 2005	pulmonary hypertension	Bayer	Completed	No outcome recorded
Phase 3	NCT00004786	Dec 1995 → ?	Raynaud disease, systemic sclerosis	National Center for Research Resources (NCRR)	Completed	No outcome recorded

Phase 48 trials · 1 missed
Phase 4	NCT07713914	Jul 2026 → Jul 2028 expected	pulmonary arterial hypertension	University of Sao Paulo General Hospital	Recruiting	No outcome recorded
Phase 4	NCT03620526	Nov 2017 → Jan 2020	diastolic heart failure	National Taiwan University Hospital	Unknown	No outcome recorded
Phase 4	NCT03044314	Jul 2017 → Jun 2019	pulmonary hypertension	Duke University	Terminated	Missed primary Stop: Enrollment
Phase 4	NCT01116063	May 2010 → Jan 2013	chronic obstructive pulmonary disease	Carmel Medical Center	Unknown	No outcome recorded
Phase 4	NCT00409526	Dec 2006 → Dec 2007	pulmonary hypertension	University of Chicago	Terminated	No outcome recorded
Phase 4	NCT00403650	Nov 2006 → Jul 2008	pulmonary arterial hypertension, sarcoidosis	University of Cincinnati	Completed	No outcome recorded
Phase 4	NCT01718288	Nov 2006 → Mar 2011	peripheral arterial disease	Fadoi Foundation, Italy	Completed	No outcome recorded
Phase 4	NCT02170519	Sep 2006 → Jan 2009	pulmonary hypertension	Duke University	Terminated	No outcome recorded
Phase not applicable13 trials · 1 missed
—	NCT07263958	Dec 2025 → Jun 2026 overdue	chronic obstructive pulmonary disease, pulmonary hypertension owing to lung disease and/or hypoxia	University of Sao Paulo General Hospital	Not yet recruiting	No outcome recorded
—	NCT04927039	Jun 2021 → Jun 2023	—	Yonsei University	Unknown	No outcome recorded
—	NCT04598191	Nov 2020 → Dec 2022	coronary artery disorder	Yonsei University	Unknown	Missed primary
—	NCT04583046	Nov 2020 → Sep 2025	lung cancer	Yonsei University	Completed	No outcome recorded
—	NCT03936140	Jan → Oct 2018	lung cancer	Seoul St. Mary's Hospital	Completed	No outcome recorded
—	NCT03365479	May 2017 → Aug 2018	pulmonary arterial hypertension	University of Giessen	Completed	No outcome recorded
—	NCT03380325	May 2016 → Jun 2017	type 2 diabetes mellitus	Amsterdam UMC, location VUmc	Completed	No outcome recorded
—	NCT02784899	Oct 2015 → Jun 2017	lung cancer	Yonsei University	Completed	No outcome recorded
—	NCT02490657	Jul 2015 → May 2016	chronic obstructive pulmonary disease	Yonsei University	Completed	No outcome recorded
—	NCT01319045	Jun 2011 → May 2013	Eisenmenger syndrome, congenital heart disease	University of California, Los Angeles	Terminated	No outcome recorded Stop: Enrollment
—	NCT00561223	Nov 2006 → Apr 2008	chronic obstructive pulmonary disease, pulmonary hypertension	University of Oklahoma	Completed	No outcome recorded
—	NCT00216931	May 2006 → Oct 2008	pulmonary hypertension, respiratory system disorder	Lund University Hospital	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT00235521	May 2005 → Oct 2008	pulmonary hypertension	Heidelberg University	Completed	No outcome recorded

Comparator or background therapy8 trials
Phase 2	NCT03867097 Comparator	Mar → Aug 2019	systemic sclerosis	Civi Biopharma, Inc.	Completed	No outcome recorded
Phase 2	NCT02238535 Comparator	Sep 2014 → Mar 2016	pulmonary hypertension	Meshalkin Research Institute of Pathology of Circulation	Unknown	No outcome recorded
Phase 2	NCT01320878 Comparator	Oct 2007 → Jul 2009	pulmonary hypertension	Shanghai Jiao Tong University School of Medicine	Completed	No outcome recorded
Phase 2	NCT00622687 Comparator	Sep 1997 → Dec 2003	systemic sclerosis	Charite University, Berlin, Germany	Terminated	No outcome recorded
Phase 3	NCT04040322 Comparator	Oct 2019 → Jun 2021	Raynaud disease	Civi Biopharma, Inc.	Completed	No outcome recorded
Phase 3	NCT03111212 Comparator	Jun 2019 → May 2021	adult acute respiratory distress syndrome	University Hospital Tuebingen	Completed	No outcome recorded
Phase 4	NCT00120380 Comparator	Sep 2004 → May 2006	hypertensive disorder	Hannover Medical School	Terminated	No outcome recorded
—	NCT05204784 Comparator	Feb 2022 → Dec 2023	Raynaud disease, chronic ulcer of skin, systemic sclerosis	Peter Korsten	Unknown	No outcome recorded

Press releases naming this drug 3 releases

Date	Issuer	Release
2025-12-18	Advanz Pharma	ADVANZ PHARMA Acquires Territory Rights to Progynova® and Cyclo-Progynova® in Selected Countries in EMEA and Global Rights to Ilomedin® advanzpharma.com ↗
2024-10-21	Orphan Australia	SERB Pharmaceuticals expands leading emergency care portfolio with acquisition of Aurlumyn™ (iloprost IV) for severe frostbite serb.com ↗
2020-10-01	Civi Biopharma, Inc.	CiVi Biopharma Resumes AURORA Phase 3 Clinical Trial of CIVI030 to Treat Systemic Sclerosis On Track to Complete Enrollment in First Quarter 2021 and for Top Line Data in Mid-2021 CHEVY CHASE, MD, October 1, 2020 – CiVi Biopharma, Inc., (“CiVi” or “the Company”), a privately held company focused on creating novel therapies against diseases where the unmet medical need exists, today announces that the Company, through its wholly-owned subsidiary, Eicos Sciences, Inc., has resumed recruitment in the AURORA Phase 3 clinical trial of the Company’s lead product, CIVI030 (intravenous iloprost), for the treatment of Systemic Sclerosis (SSc). The AURORA study was paused due to the COVID-19 pandemic in March 2020. The AURORA study is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 study evaluating the safety and efficacy of intravenous (IV) iloprost in patients with SSc experiencing symptomatic digital ischemic episodes (symptomatic Raynaud’s Phenomenon). Patients will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day. The primary efficacy endpoint is the change in the weekly frequency of symptomatic Raynaud’s Phenomenon (RP) attacks from baseline to Day 21. Secondary endpoints will evaluate severity of RP attacks as determined by symptoms, duration of attacks and percentage of patients who reach a pre-defined symptomatic response. The study is targeted to enroll approximately 180 patients across 30 U.S. sites. The Company expects to complete enrollment in the first quarter of 2021 and to have topline data in mid-2021. “In people with SSc, digital ischemic episodes (RP) are often excruciatingly painful and associated with varying symptoms of pain, numbness, tingling, and discomfort. This causes significant disability and impacts quality-of-life and day-to-day functioning and may be the initial sign of long-term progressive complications due to inflammation and scarring of the vessels that supply blood to the digits,” said Dinesh Khanna, M.D., Professor of Medicine at University of Michigan and Chief Medical Officer of Eicos Sciences. “We look forward to completing enrollment in this registrational study as there are currently no U.S. Food and Drug Administration (FDA) approved therapies to improve symptoms in patients with SSc ,” stated Shalom Jacobovitz, Chief Executive Officer of CiVi Biopharma. “Completing this pivotal study will bring us one step closer to achieving our goal to develop the first FDA -approved treatment that can improve outcomes in patients experiencing this painful and debilitating condition.” CIVI030 has been granted Orphan Drug Designation by the U.S. FDA, which provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved.1 civibio.com ↗

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 75 sources stand behind the page.

Field	Value	Cited text
Known as	iloprost	“Addition of a prostacyclin pathway agent (inhaled iloprost or oral selexipag) to ongoing dual therapy with an endothelin receptor antagonist and sildenafil as part of...” NCT07713914 ↗ 70 “L608 is developed by Pharmosa Biopharm Inc. (PBI) as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with WHO Group 1 PAH.” NCT06429930 ↗ “Standard of care treatment consists of intravenous iloprost infusions at a dose of 0.5-2 ng/kg/min administered over at least 6 hours as per local standard” NCT05204784 ↗ “3000 ng of iloprost (Ilomedin), diluted in 15ml saline solution, were injected into the common femoral artery.” NCT01774058 ↗ “20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer” NCT02032836 ↗ NCT00708565 ↗ NCT03044314 ↗ NCT00709098 ↗ NCT04543682 ↗ NCT03903939 ↗ NCT00981591 ↗ Show 60 more sources
Known as	Aurlumyn	ChEMBL registry synonym — accepted as the source's own label CHEMBL494 ↗
Known as	BAYQ6252	“lloprost(Ventavis,BAYQ6252, 20 µg/mL)” NCT02032836 ↗
Known as	BAYQ6256	“Iloprost (Ventavis inhaled, BAYQ6256)” NCT01469169 ↗ 2 “Ventavis (Iloprost, BAYQ6256)” NCT00185315 ↗ “Ventavis (Iloprost, BAYQ6256)” NCT00414687 ↗
Known as	Ciloprost	ChEMBL registry synonym — accepted as the source's own label CHEMBL494 ↗
Known as	Endoprost	ChEMBL registry synonym — accepted as the source's own label CHEMBL494 ↗
Known as	Ilomedin	“3000 ng of iloprost (Ilomedin), diluted in 15ml saline solution, were injected into the common femoral artery.” NCT01774058 ↗ 2 NCT01179776 ↗ NCT01532544 ↗
Known as	Ventavis	“Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery” NCT00235521 ↗ 14 “Ventavis® is the commercial brand name for inhaled iloprost in Brazil.” NCT07263958 ↗ “2 inhalations per day of 2.5 µg Iloprost \[Ventavis®\] per inhalation” NCT02482402 ↗ “iloprost inhalation solution (Ventavis) (5 μg)” NCT00302211 ↗ “Iloprost 10μg of inhaled iloprost (Ventavis®)” NCT03936140 ↗ “20μg (2ml) of inhaled iloprost (Ventavis®)” NCT04927039 ↗ “20μg(2ml) of inhaled iloprost (Ventavis®)” NCT02784899 ↗ “BAYQ6256 (Iloprost; Ventavis) Inhalation” NCT02032836 ↗ “Iloprost Inhalation Solution (Ventavis)” NCT00453414 ↗ “Iloprost Inhalation Solution (Ventavis)” NCT00109681 ↗ “Iloprost (Ventavis inhaled, BAYQ6256)” NCT01469169 ↗ Show 4 more sources
Known as	ZK 00036374	ChEMBL registry synonym — accepted as the source's own label CHEMBL494 ↗
Known as	ZK-36374	ChEMBL registry synonym — accepted as the source's own label CHEMBL494 ↗
Action	Activate	“trials of inhaled prostacyclin agonists such as iloprost for the treatment of asthma” NCT01209533 ↗ 1 “Prostanoid IP receptor agonist” CHEMBL494 ↗
Modality	Other / unclassified	“oral iloprost, a prostacyclin analog” NCT00004786 ↗
Route	Oral	“Patients receive oral iloprost or placebo twice daily for 6 weeks.” NCT00004786 ↗
Target	PTGIR	“Prostanoid IP receptor agonist” CHEMBL494 ↗