In short
Darizmetinib hydrochloride (HRX215) is an investigational, first-in-class liver-regenerating drug currently being studied in a Phase 1 clinical trial in people who have had liver surgery for colon carcinoma metastases. The trial (NCT06638502) is authorised and plans to enrol 79 participants. It is the only registered trial for this substance in the data provided, and it focuses on safety, tolerability, and how the body processes the drug after minor or major liver surgery.
Key points
- Darizmetinib hydrochloride (HRX215) is an investigational drug that targets the stress-signalling protein kinase MKK4 to promote liver regeneration.
- A Phase 1 trial is authorised to study safety and tolerability in 79 participants after liver surgery for colon carcinoma metastases.
- The trial compares how the drug behaves in surgical patients with earlier data from healthy volunteers.
- Primary outcomes include adverse events, changes in vital signs and laboratory values, and pharmacokinetics such as Cmax and AUC.
- The study records safety, tolerability, and pharmacokinetics as its main focus, with no efficacy endpoint registered.
What is darizmetinib hydrochloride?
Darizmetinib hydrochloride, also known by its development code HRX215, is an investigational substance. It is described as a promising first-in-class liver-regenerating drug in Phase 1b/2a clinical development. The substance is being developed by HepaRegeniX GmbH, based in Tuebingen, Germany. It has not received marketing authorisation in the data provided and is still being studied in clinical trials.
How does darizmetinib hydrochloride work?
Darizmetinib hydrochloride targets a stress-signalling protein kinase called MKK4. By acting on this kinase, the drug is intended to promote liver regeneration. MKK4 is part of a signalling pathway that cells use to respond to stress, and blocking or modulating it is thought to support the liver's ability to regrow after surgery. The exact downstream effects in patients are still being investigated.
Which conditions is darizmetinib hydrochloride studied for?
- Colon carcinoma metastases in the liver: The registered clinical trial studies darizmetinib hydrochloride in people who have undergone minor or major liver surgery because colon carcinoma has spread to the liver.
How is darizmetinib hydrochloride given?
In the registered trial, darizmetinib hydrochloride is given as an oral drug in the form of white opaque capsules, size 1. No other formulations or routes of administration are described in the data provided.
What do the clinical trials show?
One clinical trial is registered for darizmetinib hydrochloride in the data provided. The trial (NCT06638502) is a Phase 1 study that is authorised but not yet reporting results. It plans to enrol 79 participants who have had minor or major liver surgery due to colon carcinoma metastases.
The study measures the incidence, severity, and relatedness of adverse events and serious adverse events, changes from baseline in vital signs and physical examination findings, and changes in clinical laboratory parameters such as haematology and blood glucose. It also measures plasma pharmacokinetics, including Cmax, Tmax, and AUC, which describe how much of the drug reaches the blood, how quickly it reaches its highest level, and how much of the drug stays in the blood over time. These results are compared with Phase 1 pharmacokinetic data from healthy subjects.
What side effects are known?
The published source describes darizmetinib hydrochloride as a promising drug in clinical development but does not provide a list of side effects. The registered trial is designed to collect information on adverse events and serious adverse events, so the side effect profile is still being established.