HepaRegeniX

What HepaRegeniX does

HepaRegeniX GmbH is a clinical-stage biotechnology company headquartered in Tübingen, Germany, developing first-in-class orally bioavailable small molecule inhibitors of MKK4 (Mitogen-Activated Protein Kinase Kinase 4) to harness the liver's innate regenerative capacity. The company's lead candidate, HRX-215 (also known as darizmetinib), is designed to selectively inhibit MKK4 to accelerate hepatocyte regeneration, with the goal of preventing post-hepatectomy liver failure in patients undergoing liver resection (initially for colorectal cancer liver metastases), enabling extended resections for otherwise inoperable patients, and supporting living donor liver transplantation with smaller grafts. A second program, HRX-233, is being developed as a combination therapy for KRAS-driven cancers to overcome resistance to KRAS inhibitors. The MKK4 target was originally discovered by scientific co-founder Prof. Lars Zender at University Hospital Tübingen and has been validated in two Cell journal publications and a PNAS publication.

The company was founded in 2017 and is backed by a syndicate of European life science venture investors including Vesalius Biocapital IV, Wellington Partners, Novo Holdings, Boehringer Ingelheim Venture Fund, Coparion, High-Tech Gründerfonds, and Ascenion GmbH, with cumulative disclosed funding of approximately €36.5 million across a 2020 Series B and a 2024–2025 Series C. HRX-215 completed a Phase I trial in 48 healthy volunteers in 2022 with no drug-related adverse events, and a Phase Ib minor resection study at Mayo Clinic was completed in February 2026 with DSMB-confirmed favorable safety, supporting advancement to a Phase IIa major resection cohort in 85 patients across the U.S., Europe, and Israel by end of 2026. The company holds a 11–50 employee headcount, has no commercial products, and is led by CEO Elias Papatheodorou (formerly Chair, prior CEO of Genkyotex), COO and co-founder Dr. Wolfgang Albrecht, and CMO Dr. Linda Greenbaum (former Novartis executive director and UPenn hepatologist), under Chair Dr. Martin Bonde.

HepaRegeniX's business model is presently pre-revenue, with future revenue contemplated through either direct commercialization of approved therapeutics (distributed via hospital and specialty pharmacy channels) or out-licensing of regional development and commercialization rights to larger pharmaceutical partners. The go-to-market pathway proceeds through standard regulatory approval and pharmaceutical distribution once clinical milestones are achieved. Until then, the company is funded by equity capital deployed against clinical trial execution and platform expansion across hepatology and oncology indications.

Name

HepaRegeniX

Legal name

HepaRegeniX GmbH

Website

https://heparegenix.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

HepaRegeniX is a Tübingen-based clinical-stage biotech developing first-in-class oral MKK4 small molecule inhibitors (HRX-215/darizmetinib and HRX-233) to enhance liver regeneration in patients requiring resection or transplantation and to treat KRAS-driven cancers.

Ownership category

akta.pro rank

Product category

Pharmaceutical drug development for liver diseases

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Liver regeneration therapeutics
• MKK4 inhibitor drugs
• Small molecule pharmaceuticals
• Hepatology drug development
• Clinical-stage biotechnology

Headquarters

HQ city

Ulm

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Development and Commercialization: Pre-revenue clinical-stage biotech company developing novel therapies for acute and chronic liver diseases. The company aims to commercialize its drug candidates (HRX-215/darizmetinib for liver regeneration, HRX-233 for oncology) through regulatory approval and subsequent pharmaceutical sales.
2. Licensing and Partnership Deals: Potential for licensing agreements with larger pharmaceutical companies for development and commercialization rights in various territories.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

HepaRegeniX is a clinical-stage biotech developing first-in-class, orally administered small molecule inhibitors of MKK4 to accelerate and enhance liver regeneration. The lead candidate HRX-215 (darizmetinib) targets post-hepatectomy liver failure and liver transplantation applications, while HRX-233 is being developed as combination therapy for KRAS-driven cancers. Products are intended for hospital-based prescription following regulatory approval.

Product overview

HepaRegeniX is a clinical-stage biotech company developing novel small molecule therapeutics based on MKK4 inhibition. The company's lead product HRX-215 (darizmetinib) is a first-in-class oral small molecule MKK4 inhibitor designed to unlock liver regeneration. The company is also developing HRX-233 for KRAS-driven cancer combination therapy. The therapeutic approach harnesses the liver's inherent regenerative capacity by inhibiting MKK4, a master regulator of liver regeneration.

Differentiator

Problem solved

Functional benefit

Products and services

• HRX-215 (Darizmetinib) First-in-class, orally available small molecule inhibitor of MKK4 (Mitogen-Activated Protein Kinase Kinase 4) designed to accelerate and enhance liver regeneration. Currently in Phase Ib/IIa clinical development for preventing post-hepatectomy liver failure in patients undergoing liver resection (particularly for colorectal cancer liver metastases) and for enabling liver transplantation with smaller grafts.
• HRX-233 Small molecule inhibitor of MKK4 with distinct pharmacokinetic properties being developed as combination therapy for KRAS-driven cancers to overcome resistance to KRAS inhibitors. Targeted indications include colorectal, pancreatic, and lung cancers with KRAS mutations.

Quantifiable outcome

• Improved survival in 85% liver resection pig model - typically lethal condition made survivable with HRX-215 treatment
• +2 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered strategic and minor.

• Netherlands Cancer Institute (NKI)strategicStrategic or Co-development Partner · 20 October 2021Preclinical collaboration to explore HRX-0233 (renamed HRX-233) for KRAS-driven cancer combination therapy. Prof. René Bernards' group at NKI is conducting preclinical research to identify promising combinations of MKK4 inhibitors with other MAP kinase pathway inhibitors. Preliminary in vitro data showed promising synergy results.
• University Hospital TübingenstrategicStrategic or Co-development PartnerFoundational research collaboration where company co-founder Prof. Lars Zender's group discovered the MKK4 molecular target. Ongoing collaboration for preclinical and clinical research including work published in Cell journal.
• Mayo ClinicstrategicStrategic or Co-development PartnerClinical and preclinical collaboration with Prof. Scott L. Nyberg's team at Mayo Clinic Rochester, MN, USA. Mayo Clinic conducted pivotal preclinical studies in pig hepatectomy models and serves as clinical trial site for Phase Ib study of HRX-215.
• University of Tübingen (Prof. Stefan Laufer's group)minorStrategic or Co-development PartnerCollaboration for drug discovery leading to identification of HRX-0215 (original name for HRX-215), the first MKK4 inhibitor from the company's small molecule drug discovery platform.

Scale indicators4 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Madrigal Pharmaceuticals: FDA-approved developer of Rezdiffra (resmetirom) for MASH. Both companies are clinical-stage hepatology biotechs developing differentiated, mechanism-driven oral therapies for liver disease with similar go-to-market through specialty hepatology channels.
• Intercept Pharmaceuticals (now Alfasigma): Developed Ocaliva (obeticholic acid) for primary biliary cholangitis, a pioneer hepatology biotech with similar investor base and strategic trajectory (acquired by Alfasigma in 2024). Directly comparable as a hepatology-focused drug developer with similar regulatory and commercial pathway considerations.
• Mirum Pharmaceuticals: Commercial-stage hepatology company with Livmarli (maralixibat) and Cholbam. Comparable as a focused liver-disease biotech building a specialty hepatology franchise around differentiated mechanisms in rare and serious liver conditions.
• GENFIT: European hepatology biotech advancing elafibranor for PBC and other liver disease programs. Directly comparable as a European clinical-stage liver-disease developer with similar indication focus and partnership-driven commercialization strategy.
• Pliant Therapeutics: Clinical-stage biotech developing bexotegrast for PSC and other integrin-based therapies for liver fibrosis. Comparable as a clinical-stage liver-fibrosis/hepatology developer with similar trial scale and indication overlap in serious liver disease.
• CymaBay Therapeutics: Developed seladelpar for PBC (acquired by Gilead in 2024 for $4.3B). Closely comparable clinical-stage hepatology biotech with a focused, single-mechanism asset and similar strategic exit trajectory relevant to HepaRegeniX's licensing/M&A optionality.
• NGM Biopharmaceuticals: Clinical-stage biotech with aldafermin and other FGF19-pathway programs for chronic liver disease. Comparable as a hepatology-focused clinical biotech with similar investor profile (incl. overlap with HepaRegeniX backers) and indication focus in MASH/PBC-adjacent spaces.

Emerging players

• Akero Therapeutics: Clinical-stage developer of efruxifermin (FGF21 analog) for MASH with strong Phase IIb data. Comparable as a clinical-stage hepatology biotech with a differentiated, liver-targeted mechanism and similar path through late-stage trials toward a potential hepatology partnership or commercialization.
• Galmed Pharmaceuticals: Clinical-stage biotech developing Aramchol for MASH and exploring liver fibrosis indications. Comparable as a clinical-stage hepatology drug developer with a focused, single-asset strategy and similar late-stage clinical positioning in chronic liver disease.

Broad incumbents

• Boehringer Ingelheim: Large pharma with MASH programs (survodutide, partnered with Zealand Pharma) and an existing strategic investment in HepaRegeniX via BIVF. Comparable as both a potential strategic acquirer of HRX-215/233 and a competitor with overlapping hepatology indications and substantially greater development resources.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/heparegenix-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles18 records

Funding overview

Funding rounds4 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about HepaRegeniX