MipSalus Receives Approval from DKMA to Initiate First-in-Human Clinical Study for Phelimin, a Novel Treatment for Phenylketonuria (PKU).

Hørsholm, Denmark – Wednesday, June 17, 2026

The Danish Medicines Agency (DKMA) has approved an application from MipSalus to initiate a clinical phase 1 study with the title:

A phase 1 first-in-human study of a phenylalanine-binding polymer (phelimin) in healthy volunteers and adult, classical PKU patients.

The objectives of the study are safety, tolerability, and pharmacological effect of phelimin. The pharmacological effect will be assessed in classical PKU patients as a reduction in uptake of phenylalanine from dietary proteins.

The study will be conducted at Rigshospitalet, Copenhagen, Denmark, by Professor Allan Lund and the first patient is expected to be dosed in second half of 2026.

“Receiving approval to initiate our first-in-human study is a defining moment for MipSalus. We look forward to evaluating this novel approach in the clinic and generating the first human data later this year. This milestone would not have been possible without the commitment of our employees, collaborators, and investors.” said Nicolas Krogh, Chief Executive Officer of MipSalus.

For additional study info: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=da&EUCT=2024-519121-38-01