The Pharmacy and Poisons Board (PPB) has begun reviewing an application to register Mounjaro, a booming once-weekly injectable diabetes drug, for use in Kenya.
The application was submitted by Aspen Pharmacare, a South African pharmaceutical company that has an agreement with Eli Lilly, the US manufacturer of Mounjaro, to distribute and promote the drug across sub-Saharan Africa.
PPB Chief Executive Ahmed Mohamed confirmed that the application was submitted and is currently at the screening stage, the first step in the regulatory review process.
“Yes, the PPB received an application to register Mounjaro in Kenya on May 7, 2026, and it’s at the screening level,” he told the Business Daily.
The regulator's review will determine whether the product meets Kenya's requirements for quality, safety and efficacy before any approval is granted.
Until the registration process is completed, the PPB said the application does not amount to an approval for routine marketing of Mounjaro in Kenya.
Mounjaro contains tirzepatide, a prescription injectable medication used to manage Type 2 diabetes and promote chronic weight loss. If approved in Kenya, it will be prescribed alongside a healthy diet and regular exercise to treat adults, adolescents, and children aged 10 years and above, with poorly controlled Type 2 diabetes mellitus.
Tirzepatide works on two hormone pathways, GIP and GLP-1, which help regulate blood sugar and appetite. This dual action has helped make tirzepatide one of the newer treatments attracting attention in the diabetes and obesity medicine market.
The Kenyan market has seen growing demand for newer diabetes treatments, particularly GLP-1 medicines that can reduce appetite and body weight.
The country already has a range of approved semaglutide medicines, including Ozempic and Wegovy and newer semaglutide products approved by the PPB. Separately, Getz Pharma has introduced Zepad, a tirzepatide-based medicine that contains the same active ingredient as Mounjaro.
The growing interest in these medicines has also increased attention on access, affordability and the need to ensure that patients obtain genuine products through regulated supply chains.
Dr Ahmed said that the growing number of applications for newer diabetes and obesity medicines reflects the expansion of treatment options but also presents additional challenges for regulators.
“The increasing number of applications means expanding therapeutic options and building confidence in the regulatory authority,” he said.
He added that this trend also brings additional regulatory demands, including the need for more inspections due to concerns over counterfeit medicines and illegal imports, as well as the risks associated with off-label use.
The Kenyan application forms part of Aspen’s broader plan to expand Mounjaro across sub-Saharan Africa, alongside Nigeria, which are among the first target markets outside South Africa.
“We have submitted applications in Kenya and Nigeria,” Aspen CEO Stephen Saad told investors, adding that the two markets have the potential to contribute to the company’s earnings in the financial year ending June 2027.
The company expects Mounjaro sales in Africa to exceed $124 million (Sh15.9 billion) in the financial year ending June 2027, buoyed by surging demand in South Africa and planned launches in Nigeria and Kenya.
Launched late in 2024, the drug increased its market share to a dominant 53 percent from 15 percent a year earlier.
