Iran Unveils First FDA-Approved Drug for Fatty Liver Disease
WANA (Nov 05) – In a major medical breakthrough, Iranian biotech innovators have produced Resmetirom, the first FDA-approved drug for the treatment of nonalcoholic fatty liver disease (NASH). The locally manufactured version was unveiled at the “Far Iran” Innovation Exhibition, held at the Tehran International Exhibition Center from November 2 to 5.
Resmetirom is an oral medication classified as a thyroid hormone receptor beta (THR-β) agonist, designed to reduce fat accumulation and fibrosis (scarring) in the liver. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2024 for adult patients with moderate to advanced NASH (fibrosis stages F2 to F3) and has also received a conditional approval recommendation from the European Medicines Agency (EMA) in 2025.
By selectively stimulating THR-β receptors in liver cells, Resmetirom boosts fatty acid oxidation, decreases fat synthesis, and lowers liver fat levels—mechanisms that clinical trials show can reduce inflammation and improve fibrosis.
According to Dr. Sina Dastani, marketing and sales director of the Iranian pharmaceutical company behind the innovation, the domestic production of Resmetirom marks the first time any country outside the U.S. has successfully developed and released this medication.
“Our researchers carried out extensive studies in parallel with the original manufacturer to produce this drug locally,” Dastani said.
“From the outset, our focus was on patient-centered development. Fortunately, our efforts succeeded, and we are now offering the first effective chemical treatment for nonalcoholic fatty liver disease in Iran.”
He noted that, until now, no effective drug therapy existed for fatty liver disease—patients relied mostly on herbal supplements or lifestyle changes. “This medication is currently the only FDA-approved chemical treatment specifically indicated for nonalcoholic fatty liver disease,” Dastani added.
Production of the drug began about 18 months ago, and it has now entered the Iranian pharmaceutical market after obtaining regulatory clearance. Resmetirom is currently available at major pharmacies in Tehran, including 13 Aban, Red Crescent, Shahid Kazemi, and 29 Farvardin.
Dastani emphasized that patient feedback has been “highly promising” and described the achievement as “a major step toward reducing dependency on foreign imports and improving the quality of healthcare for Iranian patients.”
Fatty liver disease affects at least 30% of Iran’s population, making this development a crucial milestone in national health innovation.
Iran Unveils First FDA-Approved Drug for Fatty Liver Disease. Social media/ WANA News Agency
