Ravicti® (glycerol phenylbutyrate) approved in United Arab Emirates and Sultanate of Oman

Stockholm, March 4, 2026 - Immedica today announced that Ravicti® (glycerol phenylbutyrate) has received regulatory approval in the United Arab Emirates and the Sultanate of Oman, further expanding access to treatment for patients living with rare diseases in the region.

With this approval, Ravicti is now approved in Saudi Arabia, Kuwait, Qatar, Oman, and the United Arab Emirates, marking an important expansion of access to treatment across key markets in the Middle East.

“We are very pleased to see Ravicti approved in the United Arab Emirates and Sultanate of Oman,” said Anders Edvell, CEO of Immedica. “Ensuring broader availability of established treatments for rare diseases remains a key priority for us, and these approvals represent another meaningful step in supporting patients across these markets.”

Ashraf Attia, General Manager MENA, added: “Having Ravicti approved across these countries underscores our long-term commitment to the rare disease community in the Middle East. We appreciate the constructive collaboration with local health authorities and look forward to continuing our efforts to improve outcomes”.

About Urea Cycle Disorders (UCD)
Urea cycle disorders are a group of metabolic diseases that affect a specific enzyme or transporter in the urea cycle leading to elevated ammonia or glutamine levels in the circulation. Symptoms of the disorder can begin at any age, where more severe defects are seen with an onset of the disease early in life. UCD patients may experience episodes, called hyperammonemic crises, when ammonia levels in the blood become excessively high, which can result in irreversible brain damage, coma, or death. Beyond hyperammonemic crises there are also more subtle symptoms including vomiting, refusal to feed, irritability, muscular hypotonia as well as delayed motor and psychointellectual development. As a group, these disorders occur in 1 in 35,000 newborns.

About Ravicti® (glycerol phenylbutyrate)
Ravicti is a medicine used to treat patients of all ages with UCDs, including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

The medicine is used to reduce the amount of ammonia in the blood in order to reduce the risk of neurological consequences.

About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology, RARE Endocrinology  and specialty care. Immedica was founded in 2018 and employs today around 180 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo.

For more information visit www.immedica.com.

Immedica contact:
Linda Holmström
Head of Communication
[email protected]