Novo drops oral GLP-1 analog to focus on next-gen Rybelsus

Novo Nordisk has stopped development of its next-generation oral GLP-1 analog OG2023SC. The Danish drugmaker took the action after making progress with an enhanced version of its existing oral semaglutide formulation.

Novo won FDA approval for the first oral GLP-1 treatment for Type 2 diabetes in September. By then, work on potential successors to the oral semaglutide formulation, sold as Rybelsus, was already well underway. Novo moved oral GLP-1 analog OG2023SC, also known as NNC0113-2023, into a first-in-human study last year and wrapped up the trial in January.

Now, Novo has dumped OG2023SC. Novo said the decision was “based on the encouraging progress of the enhanced next-generation oral semaglutide formulation.”

Novo is yet to say much about its next-generation oral semaglutide formulation but in recent weeks has started two clinical trials of candidates that fit that description. The clinical trials are comparing different, new formulations of oral semaglutide, code-named C and D, to the existing product.

The summary of the trial of formulation C provides details of how it differs from the current product. The current formulation features 300 mg of SNAC, a carrier molecule that keeps GLP-1 stable in the stomach, and three “helping agents.” Formulation C contains 300 mg of SNAC and one helping agent. The summary of the trial of formulation D lacks details of how it differs from the current product.

Novo is using the same design, endpoints and enrollment criteria in the two trials, which will each recruit 240 people. The goal of both studies is to “find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation.” To answer that question, Novo is measuring how much semaglutide is taken up into the body when the two experimental and one approved formulations of the drug are administered at three dosage strengths. 

The initiation of the two studies comes as Novo seeks to capitalize on the edge its oral technology may give it in the fiercely competitive diabetes market. Rybelsus came to market on the back of a clinical trial program that saw it best drugs sold by Eli Lilly, Boehringer Ingelheim and Merck, leading analysts to tip Novo to generate blockbuster sales.