RCS - Redx Pharma Limited - US FDA lifts Partial Clinical Hold on Zelasudil

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RNS Number : 8981N  Redx Pharma Limited  07 January 2026

 

 

REDX PHARMA LIMITED

("Redx" or the "Company")

US FDA lifts Partial Clinical Hold on Zelasudil

 

Alderley Park, UK, 7 January 2026 Redx Pharma Ltd
(https://www.redxpharma.com/) , the clinical-stage, biotechnology company
focused on developing novel, small molecule, targeted medicines for fibrotic
disease announces that the Partial Clinical Hold (PCH) placed on the zelasudil
(RXC007) Phase 2a trial in Idiopathic Pulmonary Fibrosis (IPF) by the Division
of Pulmonology, Allergy, and Critical Care (DPACC) of the US Food and Drug
Administration (FDA) has been lifted.

The PCH was issued as a result of a non-clinical observation and limited the
dosing period to 28-days in the US during the initial Phase 2a study.
Following the submission of the final 12-week data, and additional 12-week
open label extension (OLE) data from the completed Phase 2a study (RXC007 /
0002) undertaken at 31 sites across Europe and the UK, the FDA have lifted the
PCH resulting in an open IND in the US to support the further clinical
development of zelasudil.

Lisa Anson, CEO, Redx Pharma, commented: "We are thrilled with the decision of
the FDA to lift the partial clinical hold placed on zelasudil following the
review of our clinical data package. This will allow the next stage of
clinical development for zelasudil to take place on a global scale. In
addition to our signal in IPF patients, our pre-clinical work has shown
zelasudil to have utility across a number of fibrotic diseases and we are
focused on bringing this exciting new therapeutic treatment option to
patients."

The Phase 2a study aimed to assess safety, tolerability, pharmacokinetic and
initial efficacy in patients with IPF. The Phase 2a data showed zelasudil to
be well-tolerated with evidence of anti-fibrotic activity supported by
circulating biomarkers and a numerical improvement in Forced Vital Capacity
(FVC) decline in patients with IPF vs placebo. The pharmacokinetic data
matched predictions from Phase 1 healthy volunteer studies and combinability
with standard of care agents was demonstrated, with no clinically relevant
drug-drug interactions seen with either nintedanib or pirfenidone.

The full Phase 2a data set was presented at the European Respiratory Society
(ERS) meeting in Amsterdam in September 2025 and is available on the Company
website at: https://www.redxpharma.com/scientific-publications/
(https://www.redxpharma.com/scientific-publications/)

The encouraging clinical data supports further investigation of zelasudil as a
potential treatment for IPF and other interstitial lung diseases and Redx is
seeking a partner to support the next stages of clinical development.

About Zelasudil (RXC007)

Zelasudil is a potential best-in-class potent, highly selective and
orally-active inhibitor that targets Rho-Associated Coiled-Coil Containing
Protein Kinase 2 (ROCK2) which sits at a nodal point in cell signalling
pathways, central to fibrosis. Redx are developing zelasudil as a potential
treatment for IPF and other interstitial lung diseases, as well as other
conditions including Metabolic dysfunction-associated steatohepatitis
(https://www.google.com/search?sca_esv=9ab8c0c46cd95f09&rlz=1C1CHBF_en-GBGB999GB999&q=Metabolic+dysfunction-associated+steatohepatitis&sa=X&sqi=2&ved=2ahUKEwjH-tXk7_SRAxVER_4FHS-nLCQQxccNegQINBAB&mstk=AUtExfDfKb7lyapiroTRiwnZIUlqZJZtkNPnjVxD3TpR6_K0WILdtSDXOSeI-UYV9Csd9flxCbmxtoE_XN1rPIaOz_15eSjPC36Ff7BbKO9UWi2_UVmDynE9d7MvGeQK0FN-3IjJ8YHJUN-yeta6dmX7fwrB112Lz3X_xuow_Y-LFp9a_bMOS1uoGhL7O8VzDMVFsRV7&csui=3)
(MASH) and cancer-associated fibrosis, where the Company has generated
supportive pre-clinical data.

 

 For further information, please contact:

 Redx Pharma Limited                                                 T: +44 (0)1625 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 FTI Consulting                                                      T: +44 (0)203 727 1000
 Simon Conway/ Ciara Martin

 

 

About Redx Pharma Limited

 

Redx Pharma is a clinical-stage biotechnology company focused on the
development of novel, small molecule, targeted medicine for the treatment of
fibrotic disease. Pioneering the next generation of anti-fibrotic medicines,
the Company is currently progressing RXC008, a first-in-class GI-restricted
pan-ROCK inhibitor for the treatment of fibrostenotic Crohn's disease through
the clinic and has completed a Phase 2a program in idiopathic pulmonary
fibrosis (IPF) with zelasudil, a potential best-in-class selective ROCK2
inhibitor.

 

Additionally, the Company has an early-stage discoidin domain receptor (DDR)
inhibitor program with potential to be a first-in-class approach for chronic
kidney disease. To date, six Redx discovered molecules have been progressed
into the clinic with the Company's accomplishments evidenced not only by its
wholly-owned clinical-stage assets and discovery pipeline, but also by its
strategic transactions including with AstraZeneca and Jazz Pharmaceuticals, as
well as the sale of pirtobrutinib (RXC005, LOXO-305) to Loxo Oncology (Eli
Lilly). Pirtobrutinib, the only approved non-covalent or reversible Bruton's
tyrosine kinase (BTK) inhibitor, has transitioned quickly from FDA approval in
the US, to broader international approvals.

 

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