KAMPALA, UGANDA — Dei BioPharma Ltd announced on Tuesday that the U.S. Food and Drug Administration has accepted the development plan for two of its novel biological drugs, liraglutide and semaglutide, which are used to treat conditions like type 2 diabetes and obesity, cardiovascular disease, heart failure and diabetic kidney disease among others.
The groundbreaking therapeutic platforms developed by scientist and inventor Dr. Matthias Magoola have both now been formally accepted by the US FDA for its development plan to enable quick approval by US agency.
On August 7, 2025, the FDA issued a written notification fully agreeing with Dei Biopharma’s plan for FDA submission.
The two products, liraglutide and semaglutide, have already been developed by Dei BioPharma, and the company is now filing for their US approval. Besides the multibillion-dollar US market, Dei BioPharma plans to distribute these products globally at an affordable cost to multitudes of patients who can not afford them due to their high prices. Dei BioPharma projects to earn revenue of USD 15 billion per year from these products once fully developed.
This marks the second time the US FDA has accepted a development plan for one of the Ugandan based biopharma’s key biological drug innovations — the first was for darbepoetin alfa biosimilar.
Dei BioPharma’s founder, scientist Dr. Magoola says the company has already completed the development of both drugs and aim to make these medications affordable worldwide, projecting to launch them within the next 18 months.
The medications are part of a class of drugs known as glucagon-like peptide-1 (GLP-1) agonists, which are among the world’s best-selling drugs.
The global market for GLP-1 agonists is currently over $100 billion, with a recent Goldman Sachs report projecting it could exceed $322 billion annually by 2035. The report also suggests GLP-1 drugs could add a trillion dollars to the U.S. GDP over the next four years.
“Our promise of making biological drugs affordable to the rest of the world is coming to fruition,” Dr. Magoola said.
Dei BioPharma projects it could earn $15 billion in annual revenue from the new products once they are launched.
The company says it is the first African firm to lead the market in this specific class of novel products, which it believes will help provide a more equitable distribution of advanced medicine.
Dei BioPharma’s mission is to deliver “cutting-edge immunological therapies that are scientifically advanced, globally accessible, and human-centered.”
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