Remodulin

(Treprostinil)

ApprovedSmall molecule

Remodulin is a small molecule that works as a Prostanoid IP Receptor Agonist; Prostanoid IP Receptor Agonist; Prostanoid IP Receptor Agonist.[2] It is being used across 22 indications, with its most advanced program in Approved.[1]

Remodulin is one of 440 small molecule programs targeting Single ventricle. It is currently in Approved.

Indications

Total Trials

Active Trials

439

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Single VentricleActive, not recruiting

Adult Acute Respiratory Distress SyndromeApproved

Persistent Fetal Circulation SyndromeApproved

Ischemia Reperfusion InjuryApproved

Raynaud DiseaseApproved

Idiopathic Pulmonary Arterial HypertensionApproved

Liver TransplantActive, not recruiting

IschemiaApproved

Kidney TransplantActive, not recruiting

Pulmonary HypertensionApproved

Single VentriclePreclinical

Active, not recruiting

Adult Acute Respiratory Distress SyndromeApproved

Approved

Persistent Fetal Circulation SyndromeApproved

Approved

Ischemia Reperfusion InjuryApproved

Approved

Raynaud DiseaseApproved

Approved

Idiopathic Pulmonary Arterial HypertensionApproved

Approved

Liver TransplantPhase 1

Active, not recruiting

IschemiaApproved

Approved

Kidney TransplantPhase 1/Phase 2

Active, not recruiting

Pulmonary HypertensionApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

557 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

Remodulin

United Therapeutics

Approved

36 2

Spiriva

Boehringer Ingelheim

Preclinical

15 3

Aclidinium Bromide

AstraZeneca

Preclinical

21 4

Formoterol Fumarate

AstraZeneca

Preclinical

11 5

Atrovent

Boehringer Ingelheim

Preclinical

5 6

Calciferol

Alnylam Pharmaceuticals

Preclinical

—7

Proventil

Mylan Pharmaceuticals Inc

Preclinical

3 8

Duragesic

CCephalon

Preclinical

2 9

Zoloft

VViatris Specialty LLC

Preclinical

1 10

Versed

CConrado Roberto Hoffmann Filho

Preclinical

—

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

Timeline

Expected Milestones

Q4 2027

Phase 2Not yet recruiting

Pulmonary Arterial Hypertension

NCT07177703

Q2 2028

Post-ApprovalActive, not recruiting

Pulmonary Arterial Hypertension

NCT05203510

Q1 2029

Post-ApprovalRecruiting

Study completion

NCT07112183

Q4 2029

Not yet recruiting

Efficacy

NCT06603285

Clinical

Trials by Indication[1]

Pulmonary Arterial Hypertension10 trials

Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

Completed·RRajan Saggar·Phase 2·NCT00705133·15 enrolled

Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07177703·32 enrolled

Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension

Unknown status·—·Phase 4·NCT03835676·30 enrolled

Show 7 more trials

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)

Completed· United Therapeutics logo

United Therapeutics·Phase 3·NCT00325442·354 enrolled

A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension

Active, not recruiting· United Therapeutics logo

United Therapeutics·Phase 4·NCT05203510·52 enrolled

An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

Withdrawn· United Therapeutics logo

United Therapeutics·Phase 4·NCT02882126

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Completed· United Therapeutics logo

United Therapeutics·Phase 3·NCT00325403·349 enrolled

TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Completed· United Therapeutics logo

United Therapeutics·Phase 4·NCT03055221·20 enrolled

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Withdrawn· United Therapeutics logo

United Therapeutics·Phase 3·NCT02999906

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

Completed· United Therapeutics logo

United Therapeutics·Phase 3·NCT01027949·894 enrolled

Pulmonary Hypertension5 trials

A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension

Completed· United Therapeutics logo

United Therapeutics··NCT01028651·13 enrolled

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Withdrawn· United Therapeutics logo

United Therapeutics·Phase 2·NCT02603068

Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study

Completed·GGuangzhou Institute of Respiratory Disease·Phase 4·NCT06605326·46 enrolled

Show 2 more trials

Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD)

Withdrawn· United Therapeutics logo

United Therapeutics·Phase 3·NCT03055234

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction

Terminated· United Therapeutics logo

United Therapeutics·Phase 3·NCT03037580·84 enrolled

ART2 trials

A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02770521·23 enrolled

Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH

Completed· United Therapeutics logo

United Therapeutics··NCT03888365·43 enrolled

Efficacy2 trials

A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin

Not yet recruiting·EExcelsior··NCT06603285·20 enrolled

Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon

Completed·—·Phase 1·NCT02583789·12 enrolled

Interstitial Lung Disease1 trial

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Completed·MMayo Clinic·Phase 2·NCT05564637·29 enrolled

15 more indications

Type 1 Diabetes Mellitus1 trial

A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05067270·40 enrolled

Medication1 trial

Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 4·NCT01268553·6 enrolled

Satisfaction1 trial

Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

Terminated· United Therapeutics logo

United Therapeutics·Phase 4·NCT00439946·8 enrolled

Fontan1 trial

Acute Effects of Inhaled Treprostinil in Fontan Patients

Terminated·—·Phase 2·NCT02769624·15 enrolled

Pediatric Patients1 trial

Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

Terminated·SStanford University·N/A·NCT02498444·34 enrolled

Tics1 trial

Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil

Completed·BBial - Portela C S.A.·Phase 1·NCT04675944·20 enrolled

Kidney Transplant1 trial

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

Recruiting·RRhode Island Hospital·Phase 1/2·NCT04005469·20 enrolled

Liver Transplant1 trial

Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation

Completed·—·Phase 1·NCT01481974·35 enrolled

Advanced1 trial

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH

Recruiting·UUniversity of Arizona·Phase 3·NCT04062565·20 enrolled

Adult1 trial

Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

Withdrawn· United Therapeutics logo

United Therapeutics·Phase 2·NCT03016468

Systemic Sclerosis1 trial

Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

Completed·SStanford University·Phase 2·NCT02663895·12 enrolled

HFpEF1 trial

Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

Terminated· United Therapeutics logo

United Therapeutics·Phase 3·NCT03043651·48 enrolled

GIST1 trial

ADAPT - A Patient Registry of the Real-world Use of Orenitram®

Active, not recruiting· United Therapeutics logo

United Therapeutics··NCT03045029·300 enrolled

Pediatric1 trial

Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years

Completed· United Therapeutics logo

United Therapeutics·Phase 2·NCT02276872·32 enrolled

Unspecified2 trials

Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

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

Open Label Treprostinil Raynaud's Study

Recruiting·—·Phase 4·NCT07112183·30 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 30, 2009

TYVASO

NDA NDA022387

Jul 30, 2018

REMODULIN

NDA NDA208276

May 23, 2022

TYVASO DPI

NDA NDA214324

Sep 28, 2023

REMODULIN

NDA NDA021272

May 23, 2025

YUTREPIA

NDA NDA213005

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Treprostinil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Treprostinil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Treprostinil. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213005). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Remodulin. U.S. Food & Drug Administration.
[6]
SEC EDGAR — United Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Prostanoid IP Receptor Agonist; Prostanoid IP Receptor Agonist; Prostanoid IP Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: United Therapeutics

Patent Landscape[5]

Patent Cliff

May 14, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10376525May 14, 2027

11357782May 14, 2027

9339507Mar 10, 2028

9358240May 5, 2028

8653137Sep 5, 2028

13 more patents

8658694Sep 5, 2028

9593066Dec 15, 2028

11723887Dec 15, 2028

7999007Mar 29, 2029

10772883Jun 11, 2030

10421729Apr 1, 2035

11744836May 5, 2037

11712442May 5, 2037

11660304May 5, 2037

10898494May 5, 2037

11744835May 5, 2037

12390475May 5, 2037

11826327Feb 3, 2042

Remodulin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q1 2029

Q4 2029

Trials by Indication[1]

Pulmonary Arterial Hypertension10 trials

Pulmonary Hypertension5 trials

ART2 trials

Efficacy2 trials

Interstitial Lung Disease1 trial

Type 1 Diabetes Mellitus1 trial

Medication1 trial

Satisfaction1 trial

Fontan1 trial

Pediatric Patients1 trial

Tics1 trial

Kidney Transplant1 trial

Liver Transplant1 trial

Advanced1 trial

Adult1 trial

Systemic Sclerosis1 trial

HFpEF1 trial

GIST1 trial

Pediatric1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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