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Drug

Treprostinil sodium

Approved · EMA

Late-stage development

Also known as Treprostinil, Yutrepia, treprostinil (as sodium).

3

Active clinical trials

1

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction)

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

A Phase I/II Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation

Clinical trial2026-04-23Results expected Q2 2028 · ClinicalTrials.gov

Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension

Clinical trial2025-12-03Results posted · ClinicalTrials.gov

A Prospective Single-arm Exploratory Study on the Efficacy and Safety of Treprostinil Injection in the Treatment of Patients With Intermediate-risk Pulmonary Arterial Hypertension

Clinical trial2025-09-17Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2025-06-01Primary completion · ClinicalTrials.gov

A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

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

Clinical trial2024-09-01Completed · ClinicalTrials.gov

TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Clinical trial2024-01-05Results posted · ClinicalTrials.gov

A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths

Clinical trial2023-10-04Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Sickle Cell Disease

Clinical trial2022-12-01Withdrawn · ClinicalTrials.gov

A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)

Clinical trial2022-06-07Results posted · ClinicalTrials.gov

Approval: Trepulmix (EMA)

Regulatory2020-04-03EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Treprostinil sodium

Aliases & brands

TreprostinilYutrepiatreprostinil (as sodium)

RxNorm CUI

342691

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2020-04-03

Latest approval

2020-04-03

Authorities

EMA

Total events

1

emaEuropean Medicines Agency· 1 event

2020-04-03Approval

Approval: Trepulmix (EMA)

Indication: Treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after… Show full indication

Treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity.

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

34

registered trials across all phases

LATEST COMPLETION 2024

3

Active studies

2

Recruiting

19

Late-stage (III+)

17

Completed

14

Discontinued

PHASE DISTRIBUTIONn = 34

Early Phase 11Phase 14Phase 1 / 22Phase 28Phase 2 / 31Phase 36Phase 411Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction)

Active, not recruitingPH IVUnited Therapeuticsn=522028

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

Unknown statusPH IVMagdi H. Yacoubn=302025

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

CompletedPH IVGuangzhou Institute of Respiratory Diseasen=462024

An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003

WithdrawnPH IVUnited Therapeutics2021

Transition From Parenteral Prostanoids to Inhaled Treprostinil

CompletedPH IVLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centern=62016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension

CompletedPH IIMayo Clinicn=292024

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

CompletedPH IVGuangzhou Institute of Respiratory Diseasen=462024

A Double-blinded, Placebo-controlled, Crossover Study to Assess Efficacy of Oral Treprostinil Titrated to Highest Tolerable Dose in 20 Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon Resistant to Vasodilatory Therapy

CompletedPH IBrigham and Women's Hospitaln=122021

A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths

CompletedPH IEli Lilly and Companyn=402021

A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)

CompletedPH IIISciPharm SàRLn=1052021

A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

CompletedPH IIStanford Universityn=122020

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.