KAMPALA, UGANDA — The U.S. Food and Drug Administration (FDA) has accepted an application from Uganda’s Dei BioPharma for the review of its Abbreviated New Drug Application (ANDA) 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, paves the way for the company’s entry into the lucrative market for GLP-1 receptor agonists, a class of drugs that includes both liraglutide and semaglutide (Ozempic). Industry analysts project that the GLP-1 market could soar from USD 53.46 billion in 2024 to over USD 322.85 billion by 2034.
Dei BioPharma, led by Ugandan scientist and entrepreneur Dr. Matthias Magoola is positioning itself as a global leader in generic versions (Biosimilars) of these drugs.
The company estimates that it could generate revenues of between USD 5–10 billion within the next three years from the marketing of these products alone.
Dr. Magoola is the founder and managing director of the biotech firm, which is based in Matugga, just outside Kampala.
In the latest innovation, the GLP-1 agonists as shown in a recent paper by Dr Magoola has changed the arena of multiple therapies, from diabetes to cancer to neurological disorder to most important the first safe drug for weight loss, an issue with most of the developed world.
Dei BioplPharma has also developed an oral dosage form in place of the current injection that will further expand the market of these drugs like liraglutide and semaglutide.
Dei BioPharma is the first company in Africa to have completed the development of these drugs and has filed evaluation papers with the US FDA.
Dei BioPharma is focused on being the first company outside of the developed countries to launch this product at an affordable price, a market that can easily grow into hundreds of billions dollars in a short time.
“It is the intent of Dei BioPharma to earn enough foreign exchange to enable Uganda to pay off all of its IMF loans and other obligations,” says Dr. Magoola.
The FDA approval comes amid a string of scientific and regulatory achievements by Dei BioPharma.
Dei BioPharma under Dr. Magoola has been recognized for success and achievements for innovative discoveries in advanced therapies.
Last year, the biotech outfit received a written response to its Pre-Investigational New Drug Application (pre-IND) questions submitted to the U.S. Food and Drug Administration (FDA) regarding the development of its lead asset, RNAT-89 (BLA-761423), an mRNA LNP formulation to express darbepoetin, as the first in class such product presented to the FDA, with the agency giving a preliminary no objection.
This product is used to treat acute kidney failure, cancer, and severe anaemia. Once fully approved, Dei BioPharma is promising affordable Biological drugs, that are currently out of reach and unaffordable to more than 80% of the people around the world.
Dei BioPharma had earlier filed the first
US-patented chemical drug using N-Isobutyll-3, 4-metheylenedioxy-trans-cinnamide compositions to treat malaria, the first mRNA universal vaccine against malaria, among other mRNA vaccines against neurodegenerative disorders, diabetes, HIV/HPV (“mNRA-Based Vaccine Composition for Inducing Immune Response Against HIV and HPV” patented under certificate number 63921929 in the USA and ten more for untreatable diseases — all inventions patented in the USA.
And just this year, 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.
This came after another USPTO acceptance on January 7, 2025, for what is being hailed as the world’s first universal Foot and Mouth Disease (FMD) vaccine.
Titled Affordable Universal Fusion Vaccine for Foot and Mouth Disease Infections, the breakthrough is expected to dramatically cut vaccine importation costs for Uganda and other countries struggling with FMD outbreaks. According to Dr. Magoola, the innovation could save the Ugandan government billions of shillings in annual veterinary spending.
To date, Dr. Magoola and his company have filed more than 100 patents with the USPTO, covering potential treatments and vaccines for a wide range of diseases, including cancer, HIV, Alzheimer’s, sickle cell disease, malaria, tuberculosis, and diabetes.
Dr. Magoola’s work has not gone unnoticed. On April 25, 2025, he received the African Excellence & Personality Award at a prestigious ceremony in Accra, Ghana. This honor comes just months after being recognized at the 2025 Ratna Pharma Awards in India for his contributions to vaccine research, and at the International Molecular Biologist Awards in December 2024, where he was named Best Researcher for his pioneering work with mRNA-based therapies and protein vaccines.
Dr. Magoola has also been nominated and confirmed a full member of Sigma Xi, a prestigious US society that brings top world scientists together.
Founded in 1886, Sigma Xi’s goals aim to honor excellence in scientific investigation and encourage cooperation among researchers in all fields of science and engineering.
Many of the world’s most influential scientists, such as Albert Einstein, Linus Pauling, Barbara McClintock, and Sally Ride, have been members of Sigma Xi.
President Yoweri Museveni recently reaffirmed his administration’s commitment to supporting Dei BioPharma’s innovations.
During an April 13 meeting with Dr. Magoola at State House Entebbe, the president pledged to fast-track regulatory reforms needed to facilitate international licensing of Ugandan-produced vaccines.
Specifically, the President called for the expedited passage of the National Drug and Health Products Act, which would allow the National Drug Authority (NDA) to attain World Health Organization Maturity Level 3 status—an essential requirement for the global certification of locally produced pharmaceutical products.
Dei BioPharma is currently constructing a state-of-the-art drugs and vaccines manufacturing facility in Matugga. Once complete, the multi-billion-dollar plant will become a strategic hub for pharmaceutical production, not just for Uganda but for the entire African continent.
“Our dream is to make Uganda a centre of pharmaceutical excellence, where African-born innovation serves the world,”
Dr. Magoola says.
As regulatory acceptance grows and international recognition mounts, Dei Biopharma is rapidly transforming from a local research initiative into a global pharmaceutical powerhouse—anchored in Africa, but reaching the world.
