The U.S. Food and Drug Administration (FDA) has accepted an Abbreviated New Drug Application (ANDA) from Uganda’s Dei BioPharma for liraglutide, a multibillion-dollar treatment for diabetes and weight loss, marketed under the brand name Victoza.
The FDA’s decision, officially recorded on April 23, 2025, clears a path for Dei BioPharma to enter the high-growth market for GLP-1 receptor agonists—a drug class that includes liraglutide and semaglutide (Ozempic). Industry analysts forecast that the GLP-1 market will grow from USD 53.46 billion in 2024 to more than USD 322.85 billion by 2034.
Led by Ugandan scientist and entrepreneur Dr. Matthias Magoola, Dei BioPharma is positioning itself as a global leader in biosimilars of these therapies. The company projects revenues between USD 5 billion and USD 10 billion over the next three years from marketing these products alone.
Based in Matugga, just outside Kampala, the biotech firm is spearheading innovative research into GLP-1 agonists. A recent publication by Dr. Magoola highlighted the drug class’s transformative potential—not only in managing diabetes but also in treating conditions ranging from cancer to neurological disorders. Most notably, GLP-1s represent the first class of drugs to offer safe and effective weight loss—addressing a major health challenge in the developed world.
Dei BioPharma has developed an oral dosage form of liraglutide and semaglutide, replacing the traditional injectable format. This innovation is expected to significantly expand the accessibility and global market for these drugs.
The company is the first in Africa to complete the development of these drugs and has submitted evaluation documents to the FDA. Dei BioPharma aims to become the first pharmaceutical firm outside the developed world to launch this treatment at an affordable price—tapping into a market that could grow into the hundreds of billions of dollars.
“It is the intent of Dei BioPharma to earn enough foreign exchange to enable Uganda to pay off all its IMF loans and other obligations,” said Dr. Magoola.
The FDA acceptance follows a series of scientific and regulatory achievements by Dei BioPharma. Last year, the company received a written response from the FDA to its Pre-Investigational New Drug Application (pre-IND) questions regarding its lead asset, RNAT-89 (BLA-761423)—an mRNA LNP formulation designed to express darbepoetin. This groundbreaking product, used to treat acute kidney failure, cancer, and severe anemia, was the first of its kind submitted to the FDA, which issued a preliminary “no objection.”
Dei BioPharma is also committed to providing affordable biological therapies, which remain out of reach for over 80% of the global population.
In addition to its recent accomplishments, Dei BioPharma previously filed a U.S. patent for a chemical drug using N-Isobutyl-3,4-methylenedioxy-trans-cinnamide compositions for malaria treatment. The company has also developed the first mRNA universal vaccine against malaria, as well as mRNA-based vaccines for neurodegenerative disorders, diabetes, HIV, and HPV. One such innovation—“mRNA-Based Vaccine Composition for Inducing Immune Response Against HIV and HPV”—was patented under certificate number 63921929 in the U.S., with ten more patents covering treatments for untreatable diseases.
On February 6, 2025, the U.S. Patent and Trademark Office (USPTO) published Dr. Magoola’s latest patent: a novel guided RNA therapy for cancer that targets and disrupts mutated genes. Just a month earlier, on January 7, the USPTO also accepted his patent for the world’s first universal Foot and Mouth Disease (FMD) vaccine, titled Affordable Universal Fusion Vaccine for Foot and Mouth Disease Infections. This innovation is expected to dramatically reduce vaccine importation costs for Uganda and other countries battling FMD outbreaks—potentially saving the Ugandan government billions of shillings in veterinary expenses.
To date, Dr. Magoola and Dei BioPharma have filed over 100 patents with the USPTO for potential treatments and vaccines covering cancer, HIV, Alzheimer’s, sickle cell disease, malaria, tuberculosis, and diabetes.
Dr. Magoola’s contributions have not gone unnoticed. On April 25, 2025, he received the African Excellence & Personality Award at a prestigious ceremony in Accra, Ghana. He was also recognized at the 2025 Ratna Pharma Awards in India for his work in vaccine research and named Best Researcher at the International Molecular Biologist Awards in December 2024 for his pioneering efforts in mRNA-based therapies and protein vaccines.
Dr. Magoola is now a full member of Sigma Xi, the prestigious U.S. scientific society that includes notable members such as Albert Einstein, Linus Pauling, Barbara McClintock, and Sally Ride. Founded in 1886, Sigma Xi honors excellence in scientific research and promotes collaboration across disciplines.
President Yoweri Museveni has expressed strong support for Dei BioPharma’s efforts. During an April 13 meeting at State House Entebbe, he pledged to fast-track regulatory reforms necessary to enable international licensing of Ugandan-made pharmaceuticals. The President specifically called for the swift passage of the National Drug and Health Products Act, which would allow Uganda’s National Drug Authority (NDA) to attain World Health Organization Maturity Level 3 certification—a key requirement for global drug approval.
Meanwhile, construction is underway on a state-of-the-art manufacturing facility in Matugga. Once completed, the multi-billion-dollar plant will become a strategic hub for pharmaceutical production across Africa.
“Our dream is to make Uganda a centre of pharmaceutical excellence, where African-born innovation serves the world,” said Dr. Magoola.
With growing regulatory acceptance and international recognition, Dei BioPharma is quickly transforming from a local research initiative into a global pharmaceutical powerhouse—rooted in Africa, but reaching the world.
