“Receiving IND clearance from the FDA is a defining moment for Relaxera and for the broader chronic heart failure field. This milestone reflects years of rigorous science and validates our approach to developing a truly differentiated, mechanism-driven therapy – treating causes not symptoms – for patients who currently have no targeted treatment options.” — CEO of Relaxera, Thomas Bernd Dschietzig

HFpEF: A High-Prevalence Disease with No Approved Disease-Modifying Therapy

HFpEF accounts for approximately 50% of all heart failure cases globally and is characterized by impaired cardiac relaxation (diastolic dysfunction), myocardial and vascular stiffness, and systemic inflammation. Despite affecting an estimated 3.5 million patients in the US and Europe combined — a number growing with the aging population and rising rates of obesity and hypertension — no pharmacological agent has demonstrated robust, disease-modifying benefit improving patient survival across the broad HFpEF population in pivotal trials. Current guideline-directed therapies primarily address symptom management, leaving the underlying pathophysiology and mortality largely untreated.

Relaxin-2: A Differentiated, Pleiotropic Mechanism Uniquely Suited to HFpEF

Relaxin-2 is a pleiotropic human peptide hormone with a uniquely broad mechanism of action that simultaneously addresses multiple core pathophysiological drivers of HFpEF — a profile no currently approved agent achieves.

Relaxin-2’s key competitive advantages rest on three complementary mechanisms: RXFP1 activation delivers vasodilation, improved renal perfusion, as well as myocardial relaxation and anti-fibrosis — directly targeting ventricular stiffness, HFpEF’s central structural defect; glucocorticoid receptor (GR) activation suppresses the systemic low-grade inflammation driving myocardial remodeling and contributes to vascular and organ protection, with particular relevance in obese and metabolically compromised patients; and the Wnt1 pathway activation supports anti-arrhythmic and rejuvenating effects on cardiomyocytes — a regenerative dimension absent from conventional therapies. Complementing this mechanistic breadth, relaxin-2’s endogenous human-sequence origin and well-characterized cardiovascular profile in pregnancy provide a de-risked safety rationale, while Relaxera’s biomarker- and imaging-driven patient stratification strategy maximizes the probability of demonstrating clinical benefit in Phase II.

“HFpEF demands a therapeutic strategy that addresses diastolic dysfunction, fibrosis, inflammation, arrhythmia, and renal involvement simultaneously. Relaxin-2 achieves this through three complementary receptor pathways — RXFP1, the glucocorticoid receptor, and Wnt1 — each contributing distinct and additive therapeutic effects. No currently approved agent comes close to this breadth of action.” — CMO of Relaxera, Marion Michaelis

Phase II Clinical Trial in Europe: Initiation in H1 2026

Relaxera plan to initiate their first Phase II clinical trial in HFpEF in the first half of 2026. The study is designed as a randomized, double-blind, placebo-controlled, multi-centre trial evaluating the dosing and efficacy of synthetic human relaxin-2 in patients with HFpEF, defined as left ventricular ejection fraction ≥ 45% with echocardiographic evidence of diastolic dysfunction and elevated filling pressures. The trial will be conducted exclusively at clinical sites across Europe, with a target enrolment of 320-350 patients.

“We have designed this Phase II trial to produce the highest-quality evidence package to guide the overall development efforts and for regulatory purposes. Our endpoints are also fully aligned with EMA guidance on HFpEF clinical development, and our biomarker strategy will allow us to identify the patients most likely to benefit.”  — Trial Principal Investigator, Stefan Anker

Strategic Partnering Process: Accelerating Global Development

In parallel with clinical development, Relaxera has formally initiated a strategic partnering process to identify a development and commercialization partner for relaxin-2 in HFpEF and potentially broader cardiovascular indications. Relaxera are actively engaging with leading pharmaceutical and specialty cardiovascular companies to explore co-development agreements, licensing transactions, and broader strategic partnerships.

The FDA IND clearance and imminent Phase II initiation significantly strengthen Relaxera’s position as the program transitions to active clinical development with full regulatory endorsement. Relaxera is supported by a recognized healthcare advisory firm in conducting the process.

“Relaxin-2 addresses a major unmet need in cardiovascular medicine, with a mechanism that targets several key drivers of HFpEF. We are actively supporting a high-quality European Phase II program and welcome discussions with partners interested in advancing innovative therapies in this field.” —Hans-Dirk Duengen, CEO of Scirent (CRO for the European SOURCE-HF-01 Phase II trial)

Parties interested in partnering opportunities are invited to contact the Relaxera team directly.

Link to the press release

The post Relaxera Receives FDA IND Clearance for Relaxin-2 in Heart Failure with Preserved Ejection Fraction and in Atrial Fibrillation and Announces European Phase II Clinical Trial Initiation in H1 2026 appeared first on Relaxera.

Title of the study:
Synthetic human relaxin-2 for patients with chronic symptomatic heart failure with preserved and mildly reduced ejection fraction (HFpEF, HFmrEF) and high fibrosis risk: A multi-center, double-blind, randomized, parallel-arm phase II trial (SOURCE-HF).
Relaxera plan to commence this study in early H2/2026.

The selection of patients for this upcoming study is the responsibility of the Prinicipal Investigators (the physicians in charge of conducting the study). Only these doctors – see list of Principal Investigators* – decide on patient enrolment.

If you are interested in participating in this study, please contact one of these doctors.

*list in preparation

in DEUTSCHLAND:

Klinische Studie “Relaxin bei Patienten mit diastolischer Herzinsuffizienz”

Relaxera plant eine klinische Phase-II-Studie, in der die vorteilhafte und vielfältige Wirkung von Relaxin-2 bei Patienten mit diastolischer Herzinsuffizienz nachgewiesen werden soll.

Titel der Studie:
Synthetisches humanes Relaxin-2 für Patienten mit chronischer symptomatischer Herzinsuffizienz mit erhaltener oder leicht reduzierter “ejection fraction” (HFpEF, HFmrEF) und hohem Fibrose-Risiko: eine multi-zentrische, doppel-blinde, randomisierte, Parallel-Arm Phase II Studie (SOURCE-HF).
Relaxera plant, mit dieser Studie zu Beginn von H2/2026 zu beginnen.

Die Auswahl der Patienten für diese bevorstehende Studie liegt in der Verantwortung der „Prinicipal Investigators“, also der für die Durchführung der Studie verantwortlichen Ärzte. Nur diese Ärzte – siehe Liste der Principal Investigators* – entscheiden über die Aufnahme der Patienten.
Wenn Sie an der Teilnahme an dieser Studie interessiert sind, wenden Sie sich bitte an einen dieser Ärzte. (*Liste in Vorbereitung)

In zwei Interviews zu den Themen

“Von der Forschung zur klinischen Anwendung von Relaxin”
und
“Medizinische Herausforderung Herzinsuffizienz”

erläutert Prof. Dr. Thomas Bernd Dschietzig das Potential des natürlichen Hormons Relaxin für die therapeutische Anwendung.

The post Clinical Study “Relaxin-2 for Patients with chronic symptomatic Heart Failure” appeared first on Relaxera.

The post Relaxera and University of Pittsburgh announce research cooperation appeared first on Relaxera.