Dei BioPharma Ltd, a Ugandan-based pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its development plan for two novel biological drugs—liraglutide and semaglutide—used in the treatment of type 2 diabetes, obesity, cardiovascular disease, heart failure, and diabetic kidney disease.
The FDA issued formal written notification on August 7, 2025, confirming its agreement with Dei BioPharma’s submission strategy, paving the way for accelerated approval of the two drugs in the U.S. market.
Both medications have already been developed by Dei BioPharma under the leadership of scientist and inventor Dr. Matthias Magoola.
The company is now filing for U.S. approval while preparing to distribute the drugs globally at affordable prices. Dei BioPharma projects potential annual revenues of up to USD 15 billion from the two products once fully commercialized.
This is the second time the U.S. FDA has accepted a development plan from Dei BioPharma. The first was for its darbepoetin alfa biosimilar, another key biological drug innovation.
Dr. Magoola, the company’s founder, said the development marks a major step in bringing affordable advanced therapies to patients worldwide.
“Our promise of making biological drugs affordable to the rest of the world is coming to fruition. We have completed development and aim to launch within the next 18 months,” he said.
Liraglutide and semaglutide belong to a class of medications known as glucagon-like peptide-1 (GLP-1) agonists, currently among the world’s best-selling drugs. According to Goldman Sachs, the global GLP-1 market, valued at over USD 100 billion today, could grow to USD 322 billion annually by 2035. The report also predicts GLP-1 therapies could add USD 1 trillion to the U.S. GDP within four years.
Dei BioPharma says it is the first African company to spearhead innovation in this specific drug class, positioning itself as a global player while advancing equitable access to life-saving medicine.
The company’s mission is to deliver “cutting-edge immunological therapies that are scientifically advanced, globally accessible, and human-centered.”
