Aurlumyn

(iloprost)

ApprovedSmall molecule

Iloprost injection is used to treat severe frostbite by relaxing blood vessels to improve blood flow to affected areas.[2] Aurlumyn is currently approved and in use across 18 indications[4].[1]

Aurlumyn is one of 322 small molecule programs targeting Recurrent thrombophlebitis. It is currently in Approved.

Indications

Total Trials

Active Trials

321

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Recurrent ThrombophlebitisActive, not recruiting

Essential HypertensionActive, not recruiting

Peripheral Arterial DiseaseActive, not recruiting

Systemic SclerodermaApproved

Lung CarcinomaApproved

Multiple Organ FailureApproved

Adult Acute Respiratory Distress SyndromeApproved

Myocardial InfarctionApproved

Humerus FractureApproved

Raynaud DiseaseApproved

Recurrent ThrombophlebitisApproved

Active, not recruiting

Essential HypertensionPreclinical

Active, not recruiting

Peripheral Arterial DiseasePreclinical

Active, not recruiting

Systemic SclerodermaApproved

Approved

Lung CarcinomaApproved

Approved

Multiple Organ FailureApproved

Approved

Adult Acute Respiratory Distress SyndromeApproved

Approved

Myocardial InfarctionApproved

Approved

Humerus FractureApproved

Approved

Raynaud DiseaseApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Aurlumyn

BBTG International Inc.

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Emtriva

Gilead

Preclinical

1 4

Lamprene

Novartis

Preclinical

1 5

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 6

Theo-Dur

Pfizer

Preclinical

1 7

Foscavir

CClinigen, Inc.

Preclinical

6 8

Valium

Akero Therapeutics

Preclinical

2 9

Sirturo

WWim Janssens

Preclinical

1 10

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Acute Respiratory Failure

NCT06319274

Q2 2028

Not yet recruiting

Frostbite

NCT07450469

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension8 trials

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00709098·49 enrolled

Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial Hypertension

Completed·GGachon University Gil Medical Center··NCT01054105·73 enrolled

Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)

Completed· Bayer logo

Bayer··NCT02826252·64 enrolled

Show 5 more trials

Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation

Completed· Bayer logo

Bayer··NCT01894035·13 enrolled

Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS)

Completed· Bayer logo

Bayer··NCT01062282·41 enrolled

Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension

Completed· Bayer logo

Bayer··NCT03293407·31 enrolled

Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension

Completed·UUniversity of Giessen·N/A·NCT03365479·30 enrolled

Iloprost Power 15 in Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00709956·64 enrolled

Pulmonary Hypertension4 trials

Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

Completed·UUniversity of Cincinnati·Phase 4·NCT00403650·20 enrolled

Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Completed· Bayer logo

Bayer··NCT01971450·89 enrolled

Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

Completed· Bayer logo

Bayer··NCT00250640·106 enrolled

Show 1 more trial

Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients

Unknown status·—·Phase 3·NCT01712997·90 enrolled

Lung Cancer3 trials

Iloprost in Preventing Lung Cancer in Former Smokers

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02237183·34 enrolled

Oral Iloprost for the Prevention of Lung Cancer In Former Smokers

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05411107

Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease

Completed·UUniversity of Colorado, Denver·Phase 2·NCT00084409·152 enrolled

Chronic Obstructive Pulmonary Disease2 trials

Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01437878·2 enrolled

Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)

Completed·UUniversity of Oklahoma·N/A·NCT00561223·10 enrolled

Ischemia2 trials

Iloprost Therapy in Patients With Critical Limb Ischemia

Completed· Bayer logo

Bayer··NCT01458041·126 enrolled

Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)

Completed·FFadoi Foundation, Italy·Phase 4·NCT01718288·150 enrolled

22 more indications

Septic Shock2 trials

ILOPROST in Septic Shock With Persistent Microperfusion Defects (I-MICRO)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03788837·240 enrolled

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure

Completed·JJakob Stensballe, MD, PhD·Phase 2/3·NCT04123444·279 enrolled

Vasoconstriction2 trials

Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude

Unknown status·VVA Loma Linda Health Care System·Phase 1·NCT00708565·50 enrolled

Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude

Withdrawn·LLoma Linda University·Phase 1·NCT00724321

Systemic Sclerosis2 trials

Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

Terminated·—·Phase 2·NCT00622687·50 enrolled

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004786·200 enrolled

Frostbite1 trial

Field Study on Intravenous Iloprost for Treatment of Severe Frostbite at High Altitude

Not yet recruiting·—··NCT07450469·10 enrolled

Endothelial Dysfunction1 trial

Endothelial Dysfunction in Resuscitated Cardiac Arrest

Completed·PPär Johansson·Phase 2·NCT02685618·50 enrolled

Asthma1 trial

Inhaled Iloprost in Mild Asthma

Completed·VVanderbilt University·Phase 1·NCT01209533·24 enrolled

Acute Respiratory Distress Syndrome1 trial

Iloprost in Acute Respiratory Distress Syndrome

Completed·UUniversity Hospital Tuebingen·Phase 3·NCT03111212·150 enrolled

Cardiac Surgical Patients1 trial

Iloprost in High Risk Cardiac Surgical Patients

Completed·LLudwig-Maximilians - University of Munich·Phase 3·NCT00927654·253 enrolled

Efficacy1 trial

Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study

Completed· Bayer logo

Bayer·Phase 3·NCT01469169·27 enrolled

Type 2 Diabetes1 trial

The Effect of Iloprost on Capillary Recruitment and Insulin Sensitivity in Type 2 Diabetes

Completed·AAmsterdam UMC, location VUmc·N/A·NCT03380325·15 enrolled

Haemorrhagic Shock1 trial

Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure

Completed·PPär Johansson·Phase 2·NCT03903939·228 enrolled

One-lung Ventilation1 trial

Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation

Completed·YYonsei University·N/A·NCT02784899·40 enrolled

Acute Respiratory Failure1 trial

Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure

Recruiting·PPär Johansson·Phase 2·NCT06319274·450 enrolled

Congenital Heart Disease1 trial

Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease

Terminated·UUniversity of California, Los Angeles·N/A·NCT01319045·5 enrolled

Treatment1 trial

Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Withdrawn·LLund University Hospital·N/A·NCT00216931·40 enrolled

Heart Failure1 trial

Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03620526·34 enrolled

Respiratory Failure1 trial

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in COVID-19 Patients With Respiratory Failure

Completed·PPär Johansson·Phase 2·NCT04420741·80 enrolled

Coronary Artery Bypass1 trial

Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Unknown status·YYonsei University·N/A·NCT04598191·100 enrolled

Pregnancy1 trial

Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)

Unknown status·FFertility Specialists of Houston··NCT01549171·100 enrolled

Critical Care1 trial

Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients

Withdrawn·SSeattle Children's Hospital·Phase 1/2·NCT00981591

Nephropathy1 trial

Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention

Completed·OOnassis Cardiac Surgery Centre·Phase 2/3·NCT00345501·208 enrolled

Unspecified2 trials

Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Completed·UUniversity Hospital, Grenoble·Phase 1/2·NCT01082484·20 enrolled

Iloprost Effects on Gas Exchange and Pulmonary Mechanics

Completed·UUniversity of Oklahoma·Phase 1·NCT01274481·20 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 8, 2005

VENTAVIS

NDA NDA021779

Feb 13, 2024

AURLUMYN

NDA NDA217933

Feb 13, 2024

AURLUMYN

NDA NDA217933

Sources

References

[1]
ClinicalTrials.gov — 45 trial records for iloprost. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aurlumyn drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — iloprost compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for iloprost. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217933). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aurlumyn. U.S. Food & Drug Administration.
[7]
SEC EDGAR — BTG International Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Prostanoid IP Receptor Agonist; Prostanoid IP Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBTG International Inc.

Patent Landscape[6]

Patent Cliff

Aug 6, 2041

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12409184Aug 6, 2041

12409183Jul 18, 2044

Aurlumyn

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q2 2028

Trials by Indication[1]

Pulmonary Arterial Hypertension8 trials

Pulmonary Hypertension4 trials

Lung Cancer3 trials

Chronic Obstructive Pulmonary Disease2 trials

Ischemia2 trials

Septic Shock2 trials

Vasoconstriction2 trials

Systemic Sclerosis2 trials

Frostbite1 trial

Endothelial Dysfunction1 trial

Asthma1 trial

Acute Respiratory Distress Syndrome1 trial

Cardiac Surgical Patients1 trial

Efficacy1 trial

Type 2 Diabetes1 trial

Haemorrhagic Shock1 trial

One-lung Ventilation1 trial

Acute Respiratory Failure1 trial

Congenital Heart Disease1 trial

Treatment1 trial

Heart Failure1 trial

Respiratory Failure1 trial

Coronary Artery Bypass1 trial

Pregnancy1 trial

Critical Care1 trial

Nephropathy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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