“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.

Relaxera’s CEO Thomas Bernd Dschietzig is giving a keynote presentation, titled

“The development of human relaxin-2 for heart failure with preserved ejection fraction, HFpEF”

The presentation provides animal study data about relaxin-2 reversing left atrial enlargement, fibrosis and DD. In summary, hRlx-2 is highly effective as a candidate therapy for HFpEF. A phase-II clinical trial in HFpEF/HFmrEF patients will start in late 2025.

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Friday, 29 August – Monday, 01 September 2025
Madrid – Spain

The 2025 ESC Congress is a special edition as it comes together with the World Congress of Cardiology.
The spotlight theme is ‘Global Health,’ meaning ‘Cardiology Beyond Borders’, and therefore emphasising the evolving role of cardiovascular disease within the broader global health landscape. The Scientific Programme offers a global perspective — both geographically and across the full spectrum of cardiology.

Relaxera team is going to attend – feel free to connect with us for an on-site meeting.

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The lecture of Thomas Bernd Dschietzig is about treatment of HFpEF and focuses on pre-clinical experiments and results with relaxin-2, explaining the bolus therapy and the signalling portfolio of the native peptide.
Relaxin-2 delivery reverses diastolic dysfunction, arrhythmia susceptibility, inflammation, and excess fibrosis.
Get a summary of the presentation here an view the whole presentation using this youtube link.

Relaxera is currently preparing a phase II clinical trial in HFpEF.

The post Cardiology World Conference CARDIO 2024 appeared first on Relaxera.

The lectures focus on heart failure treatment options, HFpEF, on electrophysiology, diagnostics, operative and intervention heart failure treatment and additional with a view on several comorbidities.

On September 28, the session “Pipeline for the therapy of heart failure” (at 1 pm) includes a presentation by Thomas Dschietzig about relaxin-2 as treatment option.

The post D-A-C-H-Region Congress “Heart Failure” appeared first on Relaxera.

Featured presenters cover all aspects of basic biology and physiology, plus potential clinical applications of relaxin and related peptides.

One of our contributions will be the chairing of the session “Circulatory and Vasculatory Actions”.  As well we present new research results for cardioprotective effects of relaxin-2.

Join us to discuss with leading scientists from around the world, learn latest news from the relaxinologists …

The conference takes place at Coast Canmore Hotel and Conference Centre, Canmore, Alberta, Canada September 17 – 21, 2023.

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Prof. Andreas Grün is interviewing Prof. Dr. Thomas B. Dschietzig, CEO Relaxera.
(in German language)

interview 1 – Relaxin and heart failure; get the summary here.

interview 2 – Relaxin and transplantation medicine; get the summary here.

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“HFpEF and HFmrEF: what’s new in treatment” – “The therapeutic potential of relaxin for heart failure with preserved ejection fraction”

You will learn about relaxin-2 – Wnt1-interaction and gain insight into relaxin’s pleitropic actions and its ability to reverse maladaptive remodeling of atrial tissue and suppress fibrosis.
Read the abstract here.

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