Pulmonary Arterial Hypertension

Cardiovascular
88
Pipeline Programs
23
Companies
50
Clinical Trials
10
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
24
0
20
2
17
25
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
480%
Monoclonal Antibody
120%
+ 88 programs with unclassified modality

On Market (10)

Approved therapies currently available

U
CHEWTADZYApproved
tadalafil
Unknown Company
oral2024
Novartis
GLEEVECApproved
imatinib mesylate
Novartis
oral2001
U
IMATINIB MESYLATEApproved
imatinib mesylate
Unknown Company
oral2020
GS
LETAIRISApproved
ambrisentan
Gilead Sciences
Endothelin Receptor Antagonist [EPC]oral2007
United Therapeutics
ORENITRAMApproved
treprostinil
United Therapeutics
Prostacycline Vasodilator [EPC]oral2013
United Therapeutics
REMODULINApproved
treprostinil
United Therapeutics
Prostacycline Vasodilator [EPC]intravenous, subcutaneous2002
U
TADLIQApproved
tadalafil
Unknown Company
Phosphodiesterase 5 Inhibitor [EPC]oral2022
United Therapeutics
TYVASOApproved
treprostinil
United Therapeutics
Prostacycline Vasodilator [EPC]inhalation2009
United Therapeutics
TYVASO DPIApproved
treprostinil
United Therapeutics
Prostacycline Vasodilator [EPC]inhalation2022
U
YUTREPIAApproved
treprostinil
Unknown Company
inhalation2025

Competitive Landscape

23 companies ranked by most advanced pipeline stage

United Therapeutics
United TherapeuticsMD - Silver Spring
42 programs
6
7
7
13
Inhaled treprostinilPhase 41 trial
Intravenous TreprostinilPhase 41 trial
Intravenous/Subcutaneous Treprostinil; Oral TreprostinilPhase 41 trial
Parenteral TreprostinilPhase 41 trial
RemodulinPhase 41 trial
+37 more programs
Active Trials
NCT01494896Terminated9Est. Dec 2014
NCT03833323Withdrawn0Est. Jun 2021
NCT01321073Active Not Recruiting64Est. Dec 2032
+39 more trials
GS
Gilead SciencesFOSTER CITY, CA
5 programs
3
2
AmbrisentanPhase 41 trial
Ambrisentan plus SpironolactonePhase 41 trial
ambrisentanPhase 31 trial
ambrisentanPhase 31 trial
ambrisentanPhase 3
Active Trials
NCT00423748Completed186Est. Feb 2006
NCT00578786Completed383Est. Mar 2010
NCT00617305Completed38Est. Jul 2011
+1 more trials
Novartis
NovartisBASEL, Switzerland
4 programs
1
1
2
1
ImatinibPhase 3Small Molecule1 trial
imatinib mesylatePhase 31 trial
Imatinib mesylatePhase 2/31 trial
QCC374Phase 21 trial
Active Trials
NCT02939599Terminated5Est. Nov 2018
NCT00477269Completed59Est. Jan 2014
NCT01392469Completed21Est. Oct 2012
+1 more trials
Gossamer Bio
Gossamer BioCA - San Diego
3 programs
1
1
1
SeralutinibPhase 3Small Molecule1 trial
GB002Phase 21 trial
GB002Phase 11 trial
Active Trials
NCT03926793Completed8Est. May 2021
NCT04816604Active Not Recruiting74Est. Dec 2027
NCT06274801Active Not RecruitingEst. Dec 2026
Pulse Biosciences
Pulse BiosciencesCA - Hayward
3 programs
1
2
Inhaled Nitric OxidePhase 31 trial
Inhaled Nitric Oxide 75 mcg/kg IBW/hrPhase 31 trial
Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS DevicePhase 21 trial
Active Trials
NCT01457781CompletedEst. Jul 2016
NCT02652429UnknownEst. Dec 2023
NCT02725372TerminatedEst. Aug 2018
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
SotaterceptPhase 31 trial
MK-8892Phase 11 trial
Active Trials
NCT01934647Terminated7Est. Sep 2014
NCT05818137Completed46Est. Nov 2025
Inhibikase Therapeutics
1 program
1
IKT-001Phase 31 trial
Active Trials
NCT07365332Not Yet RecruitingEst. Dec 2029
Insmed
InsmedBRIDGEWATER, NJ
4 programs
2
1
Treprostinil PalmitilPhase 2/31 trial
Treprostinil PalmitilPhase 21 trial
Treprostinil PalmitilPhase 21 trial
Treprostinil PalmitilN/A1 trial
Active Trials
NCT06939647Available
NCT05147805Completed102Est. Mar 2025
NCT04791514Terminated1Est. Aug 2022
+1 more trials
Bial
BialPortugal - Coronado
10 programs
8
2
Oral zamicastatPhase 2Small Molecule1 trial
Oral zamicastatPhase 2Small Molecule1 trial
400 mg BIA 5-1058Phase 11 trial
BIA 5-1058Phase 11 trial
BIA 5-1058Phase 11 trial
+5 more programs
Active Trials
NCT04991181CompletedEst. May 2017
NCT07173738CompletedEst. Sep 2018
NCT04991207CompletedEst. May 2018
+7 more trials
Vigonvita
VigonvitaChina - Suzhou
3 programs
2
1
TPN171HPhase 21 trial
TPN171HPhase 11 trial
TPN171H single dosePhase 11 trial
Active Trials
NCT05948644CompletedEst. Oct 2020
NCT05208814CompletedEst. Oct 2022
NCT04483115CompletedEst. Jun 2022
R
ResVerlogiXAB - Calgary
2 programs
1
1
ApabetalonePhase 21 trial
ApabetalonePhase 11 trial
Active Trials
NCT03655704Completed7Est. Dec 2021
NCT04915300Unknown72Est. Mar 2025
Biogen
BiogenCAMBRIDGE, MA
1 program
1
Bardoxolone methylPhase 21 trial
Active Trials
NCT02036970Completed166Est. May 2018
Keros Therapeutics
Keros TherapeuticsLEXINGTON, MA
1 program
1
Dose A KER-012Phase 21 trial
Active Trials
NCT05975905Completed113Est. Mar 2025
Akros Pharma
Akros PharmaNJ - Princeton
1 program
1
JTT-251Phase 21 trial
Active Trials
NCT03789643Withdrawn0Est. Jun 2021
CP
Chugai PharmaJapan - Tokyo
1 program
1
SatralizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT05679570Active Not Recruiting20Est. Jun 2026
Pfizer
PfizerNEW YORK, NY
2 programs
2
SitaxentanPhase 15 trials
Sitaxsentan alonePhase 11 trial
Active Trials
NCT01251848Withdrawn0Est. Feb 2011
NCT01244620Terminated16Est. Dec 2010
NCT01204853Terminated2Est. Nov 2010
+3 more trials
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
1
ElafinPhase 11 trial
Active Trials
NCT03522935CompletedEst. Nov 2020
35Pharma
35PharmaQC - Montreal
1 program
1
HS235Phase 11 trial
Active Trials
NCT07143448Not Yet Recruiting40Est. Jan 2028
BioMarin Pharmaceutical
1 program
1
sapropterin dihydrochloridePhase 11 trial
Active Trials
NCT00435331Completed14Est. Oct 2008
Rhythm Pharmaceuticals
2 programs
Implantable System for RemodulinN/A
Model 10642 Implantable Intravascular CatheterN/A
Abbott
AbbottABBOTT PARK, IL
1 program
CS1N/A1 trial
Active Trials
NCT06321705Available
Bayer
BayerLEVERKUSEN, Germany
1 program
PAH medicationN/A1 trial
Active Trials
NCT03863990Completed104Est. May 2020
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
hepcidin levels and BMPR2 expressionN/A1 trial
Active Trials
NCT04086537Completed109Est. Feb 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
United TherapeuticsParenteral Treprostinil
United TherapeuticsIntravenous/Subcutaneous Treprostinil; Oral Treprostinil
United TherapeuticsSubcutaneous Treprostinil
United TherapeuticsSlow Dose Titration Group of Subcutaneous Treprostinil
Gilead SciencesAmbrisentan plus Spironolactone
United TherapeuticsRemodulin
United TherapeuticsTadalafil
United TherapeuticsTreprostinil
United Therapeuticstadalafil and ambrisentan upfront combination therapy
United TherapeuticsInhaled treprostinil
Gilead SciencesAmbrisentan
United Therapeuticstreprostinil
United TherapeuticsIntravenous Treprostinil
United TherapeuticsRemodulin
United Therapeuticstreprostinil sodium

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 4,130 patients across 50 trials

NCT05203510United TherapeuticsParenteral Treprostinil

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

Start: Oct 2022Est. completion: Apr 202852 patients
Phase 4Active Not Recruiting
NCT03497689United TherapeuticsIntravenous/Subcutaneous Treprostinil; Oral Treprostinil

EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension

Start: Jan 2019Est. completion: May 202236 patients
Phase 4Completed
NCT02882126United TherapeuticsSubcutaneous Treprostinil

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

Start: Jun 2017Est. completion: Jun 20210
Phase 4Withdrawn
NCT02893995United TherapeuticsSlow Dose Titration Group of Subcutaneous Treprostinil

Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension

Start: Feb 2017Est. completion: Apr 20180
Phase 4Withdrawn
NCT02253394Gilead SciencesAmbrisentan plus Spironolactone

The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study

Start: Sep 2015Est. completion: Feb 20182 patients
Phase 4Terminated

Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)

Start: Apr 2012Est. completion: Mar 201439 patients
Phase 4Completed

Treprostinil Combined With Tadalafil for Pulmonary Hypertension

Start: Mar 2011Est. completion: Mar 20121 patients
Phase 4Terminated

Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Start: Aug 2010Est. completion: Oct 20166 patients
Phase 4Completed
NCT01042158United Therapeuticstadalafil and ambrisentan upfront combination therapy

A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis

Start: Jan 2010Est. completion: Nov 201425 patients
Phase 4Completed
NCT00741819United TherapeuticsInhaled treprostinil

Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

Start: Sep 2008Est. completion: Dec 201073 patients
Phase 4Completed

Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)

Start: Apr 2008Est. completion: Jul 201138 patients
Phase 4Completed

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

Start: Feb 2007Est. completion: Mar 20118 patients
Phase 4Terminated
NCT03055221United TherapeuticsIntravenous Treprostinil

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

Start: Jun 2005Est. completion: Feb 201420 patients
Phase 4Completed

Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension

Start: Mar 2005Est. completion: Oct 200545 patients
Phase 4Terminated

A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension

Start: Oct 2002Est. completion: Aug 200539 patients
Phase 4Completed

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Start: Mar 2026Est. completion: Dec 2029
Phase 3Not Yet Recruiting

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

Start: Sep 2024Est. completion: Dec 2026
Phase 3Active Not Recruiting

A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

Start: May 2023Est. completion: Nov 202546 patients
Phase 3Completed

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

Start: Oct 2017Est. completion: Jun 20220
Phase 3Withdrawn
NCT02725372Pulse BiosciencesInhaled Nitric Oxide 75 mcg/kg IBW/hr

Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

Start: Apr 2016Est. completion: Aug 2018
Phase 3Terminated
NCT02652429Pulse BiosciencesInhaled Nitric Oxide

Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

Start: Mar 2016Est. completion: Dec 2023
Phase 3Unknown

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Start: Sep 2013Est. completion: Aug 2021471 patients
Phase 3Completed

A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

Start: Aug 2013Est. completion: Nov 201313 patients
Phase 3Completed
NCT01560624United TherapeuticsTreprostinil Diolamine

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

Start: Jun 2012Est. completion: Jun 2018690 patients
Phase 3Completed
NCT01557647United TherapeuticsInhaled treprostinil

Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

Start: Jun 2012Est. completion: Jun 20160
Phase 3Withdrawn
NCT01557660United Therapeuticsinhaled treprostinil

Inhaled Treprostinil for PAH: Open-label Extension

Start: Jun 2012Est. completion: Dec 20180
Phase 3Withdrawn

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Start: Apr 2011Est. completion: Oct 201221 patients
Phase 3Completed

A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Start: Aug 2010Est. completion: Nov 20102 patients
Phase 3Terminated
NCT00902174Novartisimatinib mesylate

Imatinib (QTI571) in Pulmonary Arterial Hypertension

Start: Sep 2009Est. completion: May 2011202 patients
Phase 3Completed

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

Start: Jan 2007Est. completion: Feb 2020894 patients
Phase 3Completed

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Start: Feb 2004Est. completion: Mar 2010383 patients
Phase 3Completed

Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

Start: Dec 2003Est. completion: Feb 2006186 patients
Phase 3Completed
NCT05649748InsmedTreprostinil Palmitil

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

Start: Mar 2023Est. completion: Dec 202691 patients
Phase 2/3Active Not Recruiting
NCT00477269NovartisImatinib mesylate

Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

Start: Apr 2006Est. completion: Jan 201459 patients
Phase 2/3Completed

A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).

Start: Oct 2023Est. completion: Mar 2025113 patients
Phase 2Completed

Apabetalone for Pulmonary Arterial Hypertension

Start: Oct 2023Est. completion: Mar 202572 patients
Phase 2Unknown

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Start: Mar 2023Est. completion: Oct 202429 patients
Phase 2Completed
NCT05147805InsmedTreprostinil Palmitil

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Start: Aug 2022Est. completion: Mar 2025102 patients
Phase 2Completed

Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)

Start: Jul 2022Est. completion: Jun 202620 patients
Phase 2Active Not Recruiting
NCT04791514InsmedTreprostinil Palmitil

A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)

Start: Mar 2022Est. completion: Aug 20221 patients
Phase 2Terminated

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Start: Apr 2021Est. completion: Dec 202774 patients
Phase 2Active Not Recruiting

Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

Start: Nov 2020Est. completion: Jun 2022
Phase 2Completed
NCT06009185BialOral zamicastat

Safety and Efficacy of BIA 5-1058 in PAH

Start: Jun 2019Est. completion: Feb 2022
Phase 2Completed
NCT04316143BialOral zamicastat

Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)

Start: Jun 2019Est. completion: Oct 2021
Phase 2Completed

Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension

Start: Mar 2019Est. completion: Jun 20210
Phase 2Withdrawn

Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

Start: Feb 2018Est. completion: Nov 20185 patients
Phase 2Terminated
NCT03016468United TherapeuticsParenteral Remodulin

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

Start: May 2017Est. completion: Sep 20180
Phase 2Withdrawn

Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Start: Jul 2015Est. completion: Mar 202145 patients
Phase 2Completed

Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

Start: Dec 2014Est. completion: Jun 201761 patients
Phase 2Completed
NCT02036970BiogenBardoxolone methyl

Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT

Start: May 2014Est. completion: May 2018166 patients
Phase 2Completed

Related Jobs in Cardiovascular

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

17 late-stage (Phase 3) programs — potential near-term approvals
23 companies competing in this space