RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Sequence Code 156629

Source: *****

Clinical Trials associated with Sotatercept

NCT07498803

/ Not yet recruitingPhase 2IIT

Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome

The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.
CHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.

Start Date01 Sep 2026

Sponsor / Collaborator

Philipps University of Marburg

NCT07266519

/ Not yet recruitingPhase 2IIT

SIRIUS - A Prospective, Non-randomized, Open-label, Proof-of-concept Study of Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension A Single-arm, Multi-center, Interventional Phase II Study

The study aims to see how 24 weeks of triple therapy-an endothelin receptor antagonist (ERA), a phosphodiesterase-5 inhibitor (PDE5i), and sotatercept-affects pulmonary vascular resistance (PVR) in patients with newly diagnosed pulmonary arterial hypertension (PAH). SIRIUS is a 24-week, single-arm, open-label study with up to 42 days of screening and a 28-day safety follow-up. It will enroll 25 patients and will be conducted only in countries where all treatments are available and covered. After 24 weeks, PAH treatment is decided by the doctor.

Start Date01 Jul 2026

Sponsor / Collaborator

Philipps University of Marburg

[+1]

NCT07356778

/ RecruitingPhase 4IIT

An Open-label, Randomized, Controlled Trial to Evaluate the Efficacy of Sotatercept Add-on Therapy Compared to Standard PAH Therapy With Pulmonary Vasodilators for Pulmonary Arterial Hypertension Associated With Pulmonary Vasodilator-resistant, Unrepaired Congenital Shunts (ASD, VSD, PDA) Including Eisenmenger Syndrome：SuMILE Trial

What is this study about? This study will test whether adding sotatercept to usual medicines for pulmonary arterial hypertension (PAH) can help adults who have PAH due to unrepaired congenital heart defects (atrial or ventricular septal defect, or patent ductus arteriosus), including Eisenmenger syndrome. These conditions often cause long-standing changes in the lung blood vessels and low oxygen levels.
Who can join? About 36 adults (age ≥18 years) in Japan whose PAH has not improved enough with pulmonary vasodilators may join. People with very severe symptoms (WHO class IV) or other serious illnesses will not be enrolled.
What will happen if I join?
Participants will be randomly assigned (like a coin flip, in a 2:1 ratio) to:
Sotatercept + vasodilator-based PAH care, or
vasodilator-based PAH care alone. The study lasts 24 weeks. Those who receive sotatercept will have injections every 3 weeks. All participants will have clinic visits and tests at the start, week 12, and week 24, including a 6-minute walk test (how far you can walk in 6 minutes), blood tests, questionnaires, and other heart-lung assessments used in routine PAH care.
What are the possible benefits? Sotatercept improved exercise capacity and heart-lung measures in other PAH studies, but people with unrepaired heart defects were not included. This study may or may not help you directly, but it may help doctors learn how to use sotatercept safely in this group.
What are the possible risks? Side effects seen with sotatercept include increase in haemoglobin, low platelets, nosebleeds, telangiectasia (small dilated blood vessels), bleeding, and blood clots. People with Eisenmenger syndrome can have both bleeding (for example, haemoptysis) and clotting risks. The study will check complete blood counts (CBC) regularly and adjust or pause dosing using label-based rules. Other risks are those of standard PAH care and blood tests.
Time and location The study is conducted at multiple hospitals in Japan. Study participation lasts about 6 months.
Costs and payments The study drug and study-specific tests will be provided at no cost. Usual medical care not required by the study will follow each hospital's standard billing. There is no required payment to join. Any travel reimbursement or stipends will follow site policy.
Privacy Your information will be kept confidential. Results will be shared in journals and at meetings without using your name.
Who to contact If you are interested or have questions, please contact the study team at the participating hospital.

Start Date07 Oct 2025

Sponsor / Collaborator

Kyushu University

100 Clinical Results associated with Sotatercept

100 Translational Medicine associated with Sotatercept

100 Patents (Medical) associated with Sotatercept

215

Literatures (Medical) associated with Sotatercept

06 Mar 2026·Cureus Journal of Medical Science

Sotatercept Versus Selexipag in Severe Pulmonary Arterial Hypertension: An Indirect Comparison of Efficacy Based on an Artificial-Intelligence Method That Reconstructed Patient-Level Data From Three Randomized Trials

Author: Paolì, Maria Gabriella ; Brunoro, Roberto ; Rivano, Melania ; Messori, Andrea

[This corrects the article DOI: 10.7759/cureus.103912.].

01 Mar 2026·INTERNATIONAL JOURNAL OF CARDIOLOGY

Durability of sotatercept response in pulmonary hypertension: Insights from extended real-world follow-up

Article

Author: Kidess, George G ; Basit, Jawad ; Khan, Muhammad Hashim ; Kassis-George, Hayah ; Sorci, Steven ; Jahan, Sultana ; Dani, Sourbha ; Alraies, M Chadi ; Fahed, Joud ; Bolaji, Olayiwola ; Mangeshkar, Shaunak ; Naeem, Azka

BACKGROUND:

Sotatercept, an activin receptor ligand trap, has demonstrated significant short-term hemodynamic improvements in pulmonary hypertension (PH) based on clinical trials. However, evidence regarding long-term outcomes in real-world settings remains limited.

METHODS:

Using data from the TriNetX global federated health research network covering 102 healthcare organizations, we conducted a retrospective cohort study comparing 454 patients with primary PH receiving sotatercept to 963,386 primary PH patients not receiving sotatercept. After 1:1 propensity score matching to balance baseline characteristics, we assessed outcomes and cox proportional hazards was used. Primary outcome included all-cause mortality and seondary outcome included lung transplantation and adverse events.

RESULTS:

From 156 healthcare organizations in the TriNetX Global Collaborative Network, 963,386 patients with PAH not receiving sotatercept and 454 receiving sotatercept met inclusion criteria. After 1:1 propensity matching, 346 patients per cohort were well-balanced (standardized differences <0.2). During follow-up (179 ± 103 vs 246 ± 100 days), all-cause mortality was significantly lower with sotatercept (3.2 % vs 30.4 %; absolute risk reduction 27.2 %, 95 % CI 22.0-32.4; p < 0.001). Kaplan-Meier analysis confirmed superior survival (95.5 % vs 45.2 %; log-rank p = 0.010). The composite safety endpoint occurred less frequently in the sotatercept group (10.2 % vs 26.9 %; p < 0.001).

CONCLUSIONS:

In this large real-world analysis from the TriNetX Global Collaborative Network, sotatercept use in patients with pulmonary arterial hypertension was associated with markedly lower all-cause mortality, absence of lung transplantation events, and fewer adverse outcomes compared with matched controls.

01 Mar 2026·BMJ Open

Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atrial septal defect, ventricular septal defect or patent ductus arteriosus), including Eisenmenger syndrome: the SuMILE trial

Article

Author: Ishikita, Ayako ; Kataoka, Masaharu ; Hosokawa, Kazuya ; Akazawa, Yusuke ; Ejiri, Kentaro ; Tomita, Hideshi ; Yoshida, Keimei ; Adachi, Shiro ; Tatebe, Shunsuke ; Hiraide, Takahiro ; Akagi, Satoshi ; Abe, Kohtaro ; Inami, Takumi ; Tagawa, Koshiro ; Asakawa, Soshun ; Higaki, Takashi ; Taniguchi, Yu ; Nakanishi, Naohiko ; Satoh, Taijyu ; Shinke, Toshiro

Introduction:

Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.

Methods and analysis:

The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.

Ethics and dissemination:

The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.

Trial registration number:

Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778 . Protocol version and date: V.1.3; 23 October 2025

242

News (Medical) associated with Sotatercept

11 May 2026

·www.biospace.com

United Therapeutics Corporation Presents New Data from TETON-1, ADVANCE OUTCOMES, and Additional Research in Pulmonary Hypertension and Pulmonary Fibrosis at ATS 2026

Presentations of results from the positive TETON phase 3 pivotal studies of inhaled treprostinil in idiopathic pulmonary fibrosis ( IPF ) include efficacy and safety results from TETON-1 and integrated results from TETON-1 and TETON-2 Results from the successful ADVANCE OUTCOMES study of ralinepag in pulmonary arterial hypertension ( PAH ) will be presented Additional presentations include an interim analysis from the TETON-PPF study of inhaled treprostinil in progressive pulmonary fibrosis ( PPF ), preliminary results from the PHINDER study of patients with interstitial lung disease ( ILD ) with and without pulmonary hypertension ( PH ), and interim results from the ARTISAN study of parenteral treprostinil in PAH SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced that 12 new data presentations across its commercial and development portfolio will be presented at the American Thoracic Society ( ATS ) International Conference, May 15-20, in Orlando. “We are thrilled to share additional positive data from the TETON-1 study in IPF and the ADVANCE OUTCOMES study in PAH, our pivotal studies that achieved unprecedented results in these two life-threatening diseases that have significant unmet needs. The data we are sharing from our research programs in pulmonary hypertension and ILD, including PHINDER , ARTISAN , and TETON-PPF , will also provide important clinical insights that may meaningfully impact how these devastating diseases are managed and help improve outcomes for the people living with them,” said Andrew Nelsen, PharmD, Vice President, Global Medical Affairs at United Therapeutics. Poster Presentations Include: ARTISAN Interim Analysis: Early Treatment with High-Dose Treprostinil Reduces Mean Pulmonary Artery Pressure and Improves Risk Status in Pulmonary Arterial Hypertension , Oral Session AQ19, Sunday, May 17, 9:27 - 9:39 am Patient Insights into Subcutaneous Pump Therapy in Pulmonary Arterial Hypertension , Poster Session A65, Sunday, May 17, 11:30 am - 1:15 pm Accuracy of Clinician Suspicion for Pulmonary Hypertension in Interstitial Lung Disease by Care Setting: Interim Comparison from the PHINDER Study , Poster Session B41, Monday, May 18, 11:30 am - 1:15 pm Real-world Dosing of Parenteral Treprostinil Post-Sotatercept Launch , Poster Session B67, Monday, May 18, 11:30 am - 1:15 pm Real-World Persistence to Oral Treprostinil in Patients with Pulmonary Arterial Hypertension: A Decade in Review , Poster Session B106, Monday, May 18, 2:15 pm - 4:15 pm TETON Phase 3 Clinical Trials of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis: Integrated Efficacy and Safety Results for TETON-1 and TETON-2 , Mini-Symposium B95, Monday, May 18, 3:51 pm - 4:03 pm Clinical Outcomes with Parenteral Induction Therapy in Patients with Methamphetamine-Associated PAH: A Subgroup Analysis of the EXPEDITE Study , Poster Session C65, Tuesday, May 19, 11:30 am - 1:15 pm Patient Reported Outcomes in Interstitial Lung Disease with and without Pulmonary Hypertension: Interim Results from the PHINDER Study , Poster Session C104, Tuesday, May 19, 2:15 pm - 4:15 pm TETON-1 Phase 3 Clinical Trial of Inhaled Treprostinil for the Treatment of Idiopathic Pulmonary Fibrosis , Poster Session C103, Tuesday, May 19, 2:15 pm - 4:15 pm TETON-PPF Clinical Trial of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis , Poster Session C103, Tuesday, May 19, 2:15 pm - 4:15 pm ADVANCE OUTCOMES: A Phase 3, Double-Blind, Placebo-Controlled Clinical Trial of Ralinepag for the Treatment of Pulmonary Arterial Hypertension , Poster Session D28, Wednesday, May 20, 8:15 am - 10:15 am Real-World Comparison of Antifibrotic-Treated and Untreated Patients with Idiopathic Pulmonary Fibrosis in a Commercial and Medicare Advantage Population , Poster Session D22, Wednesday, May 20, 8:15 am - 10:15 am Sponsored events include: Patients and Experts Forum, Saturday, May 16, 10:00 AM - 2:00 PM, Hyatt Regency Orlando ATS Research Program Benefit, Saturday, May 16, 6:00 pm - 7:30 pm, Hyatt Regency Orlando Sponsored Symposium: Unmet Needs in IPF – Understanding Disease Burden and Current Approaches , Monday, May 18, 1:15 pm - 2:00 pm, Innovation Theater 5 Sponsored Symposium: Treating PAH – Are We Ready to Aim Higher? Tuesday, May 19, 12:00 pm - 12:30 pm, Innovation Theater 8 About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at and follow us on LinkedIn , Facebook , and Instagram . Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others: our belief that presentations of data from our clinical studies will provide important clinical insights that can meaningfully reshape how diseases are managed and improve outcomes; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of May 11, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. Contacts For Further Information Contact: Investor Inquiries Media Inquiries communications@unither.com

30 Apr 2026

·www.fiercepharma.com

Merck's growth products Winrevair, Ohtuvayre trending in opposite directions

Merck presented mixed results in the first quarter for two of its growth products, pulmonary arterial hypertension treatment Winrevair and COPD drug Ohtuvayre. As Merck considers its life after Keytruda, much will depend on the performance of a pair of respiratory products it gained in pricey buyouts designed to cushion the blow from the megablockbuster's looming exclusivity loss, which is expected to happen near the end of the decade.When Merck reported its first-quarter earnings on Thursday, there was good and bad news on the two growth drivers, which were approved three months apart in 2024. While pulmonary arterial hypertension (PAH) treatment Winrevair continued its positive trajectory, generating sales of $525 million for a 12% sequential gain, chronic obstructive pulmonary disease (COPD) medicine Ohtuvayre took a U-turn, pulling in sales of $131 million, which were down 26% from its showing in the previous period.As for Ohtuvayre, which was gained in Merck’s $10 billion buyout of Verona Pharmaceuticals nine months ago, sales were adversely impacted by Medicare deductible resets and a CMS reimbursement change, but the company saw a positive trend at the end of the first quarter, according to chief financial officer Caroline Litchfield.“We are encouraged by the prescription trends we began to recover in March,” Litchfield said during a conference call. “Consistent with our strategy to maximize Ohtuvayre’s strong potential, we are making investments to reach more patients and physicians, which we expect will accelerate the growth in the second half of the year and beyond.” Meanwhile, all is well with Winrevair, which became a blockbuster in 2025, reaching $1.4 billion in sales in its first full year on the market. Acquiring the first-in-class activin receptor type IIA-Fc fusion protein with its $11.5 billion buyout of Acceleron in 2021 gave Merck a better chance to line up its commercial strategy, which is now bearing fruit.“In the U.S. we continued to see steady progress with more than 1,600 new patients having received a prescription and an increase in usage by patients whose background therapies do not include a prostacyclin,” Litchfield said, adding that new launches of Winrevair outside of the U.S. are contributing to the upward trajectory, too. There is much growth potential with Winrevair remaining as it nears a potential label expansion in September, when the FDA will decide on its application in newly diagnosed PAH patients who received the drug plus background therapy. Merck exceeded analyst expectations in the first quarter, achieving revenue of $16.3 billion, which was up 5% year over year. Keytruda accounted for nearly half of the company’s sales, pulling in $8.03 billion, for a 12% increase. Keytruda’s new convenient under-the-skin formulation, dubbed QLEX, drew sales of $128 million, which were up from $35 million in the fourth quarter.The company’s HPV vaccine Gardasil continued its slide, however, with sales down 19% to $1.07 billion in the quarter. Revenue from the shot has now declined by more than 50% from its first quarter sales of 2024, which were at $2.25 billion. While Merck has previously chalked up the free fall to plummeting demand in China and Japan, it is now also citing “unfavorable public-sector purchasing patterns” in the United States.Merck also saw a decline in sales for two of its other vaccines—rotavirus shot RotaTeq, which was down 10% on lower demand in China, and pneumococcal shot Vaxneuvance, which fell by 12% due to lower demand and “competitive pressures.” On the plus side, Merck's new pneumococcal vaccine, Capvaxive, realized a 33% increase thanks to launches in Europe and increased uptake in the U.S., the company said.Merck also tweaked its 2026 revenue guidance, increasing the bottom end of its window by $300 million. The new projection anticipates revenue falling between $65.8 billion and $67 billion.

AcquisitionVaccineDrug ApprovalClinical ResultFinancial Statement

30 Apr 2026

·www.biopharmadive.com

Merck still sees ‘compelling’ outlook for Terns leukemia drug

Merck & Co.s close analysis of updated data from a Terns Pharmaceuticals leukemia drug trial saved it close to $1 billion when it reached a deal to acquire the company in March, executives said Thursday.Terns was the target of a bidding war earlier this year. But regulatory filings submitted this month showed that the companys selling price came down once interested parties got a look at fresh results for TERN-701, a treatment believed to be a potential advance against chronic myeloid leukemia. It ultimately sold to Merck for $53 a share, or $6.7 billion, in a deal the pharmaceutical giant hopes will help offset the loss of revenue when the cancer immunotherapy Keytruda loses patent protection.Data presented in December suggested that treatment, TERN-701, might be superior to Novartis fast-selling Scemblix. At the time, Terns disclosed that TERN-701 induced a major molecular response, or a vast reduction in the number of diseased blood cells, in 74% of people who got it after 24 weeks.While Merck conducted due diligence, though, its scientific team saw updated results that could change how the Food and Drug Administration views TERN-701, said research chief Dean Li, on a conference call with analysts to discuss first-quarter earnings.As the data evolved and we were looking at very specific patient-level data, the company began to believe the molecular response rate would end up north of 50%, Li said. Its very important to translate whatever the [trial] abstract says to what I would say is a more conservative [analysis] consistent with regulatory standards.Still, Li added that the Merck research team believes TERN-701 will be an important step forward. We think that an MMR in that sort of range is extremely compelling, Li said. Novartis Scemblix achieved a 25% MMR rate at 24 weeks in a similar patient population.Regulatory filings have shown that, prior to Mercks final proposal, an unnamed bidder made an informal offer as high as $61 per share, plus $9 per share in conditional contingent value right payments. Merck also made a $61 per share offer, minus the CVR, before conducting due diligence. Terns ultimately accepted a lower offer.This transaction demonstrates our disciplined approach to pursuing business development when compelling science and value align, and we are confident in our belief that TERN-701 can benefit patients while generating value for our shareholders, said Merck CEO Rob Davis, on Thursdays call.The Terns deal comes amid a heightened investor focus on Mercks pipeline as Keytrudas patent protected life nears its end. Keytruda currently accounts for more than half of the companys pharmaceutical sales. Davis has stated that the company isnt looking for the next Keytruda, which hes referred to as lightning in a bottle, and implied that Merck may need to lean on multiple medicines to sustain revenue growth.Merck is pointing to several new and emerging products to help. One is a cholesterol-lowering drug called enlicitide. Others include the fast-growing blood pressure drug, Winrevair; a newer cancer medicine called Welireg; and a recently approved HIV pill called Idvynso. Two experimental medicines for lung cancer and influenza are critical to its prospects, too. '

ImmunotherapyAcquisitionPhase 1

100 Deals associated with Sotatercept

External Link

KEGG	Wiki	ATC	Drug Bank
D09670	-	-	DB12118

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder	Canada	Merck Canada, Inc.	01 Aug 2024
Pulmonary Arterial Hypertension	United States	Merck Sharp & Dohme LLC	26 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Familial Primary Pulmonary Hypertension	Phase 3	United States	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Argentina	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Australia	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Belgium	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Brazil	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Canada	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Czechia	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	France	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Germany	Acceleron Pharma, Inc.	25 Jan 2021
Familial Primary Pulmonary Hypertension	Phase 3	Israel	Acceleron Pharma, Inc.	25 Jan 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04811092 (MK-7962-005 \| A011-13 \| HYPERION, CTgov)	Phase 3	Familial Primary Pulmonary Hypertension \| Pulmonary Arterial Hypertension	321	Sotatercept (Sotatercept Plus Background Pulmonary Arterial Hypertension (PAH) Therapy)	ridzwnoyyu(irmzersmqx) = hlgkfdepxf jqtzhvtqkv (iprfrzpojp, iawdjnwleb - nvarkohaxz) View more	-	27 Apr 2026
				Placebo (Placebo Plus Background PAH Therapy)	ridzwnoyyu(irmzersmqx) = fykwjfkljv jqtzhvtqkv (iprfrzpojp, fuvljykzur - wgfnlvypfi) View more
NCT05818137 (MK-7962-020, Pubmed \| JACC Asia)	Phase 3	Pulmonary Arterial Hypertension	46	Sotatercept 0.3-0.7 mg/kg (Pulmonary Arterial Hypertension + Stable background therapy)	ygnmlcwsvp(psxanaaltz) = aecjrpcimh jnzdgrqeuz (qthdocgjvd, 27.8 - 55.5) View more	Positive	01 Mar 2026
NCT07356778 (SuMILE, Pubmed \| BMJ Open)	Phase 3	Pulmonary arterial hypertension associated with congenital heart disease	36	Sotatercept add-on therapy plus vasodilator-based PAH therapy	pdxxkhwrzx(vcfacmyntz) = bjgvlbbvga tbegmxmpyi (rcmhtegsqw ) View more	Positive	01 Mar 2026
				Vasodilator-based PAH therapy alone	skhvaunyul(ibkpkscrli) = wkahgfxxvk rlgrfvzafl (geapuiaknb, 103.0) View more
NCT04896008 (ZENITH, BusinessWire) Manual	Phase 3	Pulmonary Arterial Hypertension	172	WINREVAIR (sotatercept-csrk)	fsmocgfgsq(wcpfzmpgav) = itoibnqvtp spgbpeibor (eysamgutje ) View more	Positive	27 Oct 2025
				Placebo	fsmocgfgsq(wcpfzmpgav) = eyoocwiage spgbpeibor (eysamgutje ) View more
NCT04811092 (HYPERION, Pubmed \| N Engl J Med) Manual	Phase 3	Pulmonary Arterial Hypertension	320	Sotatercept	fwvyexlnrh(nggduyfqgk) = dmtinttxyu zcpboaesvh (oplzsoipom ) View more	Positive	23 Oct 2025
				Placebo	fwvyexlnrh(nggduyfqgk) = hfuotjtnzm zcpboaesvh (oplzsoipom ) View more
NCT04896008 (MK-7962-006 \| ZENITH, CTgov)	Phase 3	Familial Primary Pulmonary Hypertension \| Pulmonary Arterial Hypertension	173	Sotatercept (Sotatercept)	bidftqmuiq(hrujfaztjp) = erjevnwtnr ieipscjvyg (gutwpabtvq, snlmvqozad - hqxndkkbxf) View more	-	22 Aug 2025
				Placebo (Placebo)	bidftqmuiq(hrujfaztjp) = dmtqmxihrb ieipscjvyg (gutwpabtvq, agnimcisnk - vzzknlkgrc) View more
NCT04796337 (SOTERIA, Pubmed \| Eur Respir J)	Phase 3	Pulmonary Arterial Hypertension Add-on	426	Sotatercept	kkjocffrys(eacrrsfrkn) = xlogtgfiii botuzeaugb (khmcmwsvzh ) View more	Positive	01 Jul 2025
NCT04811092 (HYPERION, PipelineReview) Manual	Phase 3	Pulmonary Arterial Hypertension	320	WINREVAIR	ntxohjkovh(gryddxhvty) = WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. exflegsjwh (ucsgodmjxz ) Met	Positive	24 Jun 2025
				placebo
NCT04576988 (STELLAR, Pubmed \| Adv Ther)	Phase 3	Pulmonary Arterial Hypertension	-	Sotatercept plus background therapy (BGT)	dwltnjowuz(xtwuwduqpx) = dfkpzcdgcu kqgucoxvbj (eyiznlaanc ) View more	Positive	17 Jun 2025
				Placebo plus background therapy (BGT)	ijxwaqvjyn(amofbtoqmi) = qsuuxvqnwa gpvzldsjrr (oqggleprjj )
Indiana University Pulmonary Hypertension Registry (ATS2025)	Not Applicable	Pulmonary Arterial Hypertension NT-proBNP \| 6-minute walk test (6MWT) \| right ventricular free-wall strain (RVFWS)	51	Sotatercept	pkogynfbfx(wyjdjmwaan) = buavnklhqs lenypwysjm (nixngrzjxe, 241 - 410) View more	Positive	16 May 2025

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis