U.S. pharmaceutical company Pfizer has declared a halt to the development of an oral obesity treatment. This decision comes after some patients in clinical trials experienced liver toxicity side effects. Given that oral medications are expected to change the dynamics of the obesity treatment market, attention is focused on who will succeed first.
Pfizer announced on the 14th (local time) that it has decided to halt the development of 'danuglipron' (development code name PF-06882961), which was under development as an oral obesity treatment.
According to Pfizer, the newly discovered side effects primarily involved elevated liver enzymes. Such symptoms were observed in 1,400 patients participating in the clinical trial. Among them, one individual was confirmed to have liver damage, leading to the decision to suspend the trial.
This is the second time Pfizer announced the suspension of its oral obesity drug development. The company previously paused its oral obesity drug development, which involved taking the medication twice daily, in December 2023. Although it showed weight loss effects in phase 2b trials, side effects such as nausea, vomiting, and diarrhea occurred frequently. After participants in the clinical trial opted out of dosing, Pfizer decided not to proceed to phase 3.
Pfizer then reattempted the development of danuglipron as a once-daily dosage and began clinical trials in July of last year, but faced another setback due to side effect issues. Pfizer stated, "After reviewing all clinical trial data regarding danuglipron and recent feedback from regulatory agencies, we have made the final decision to cease research and development of danuglipron."
Several companies have entered the race to develop oral obesity medications. According to investment bank Goldman Sachs, the global obesity drug market, which is currently around 8 trillion won, is expected to grow to 130 trillion won by 2030. Developing oral medications is viewed as a key to gaining a competitive advantage within the growing obesity drug market.
The current global obesity treatment market is dominated by Denmark's Novo Nordisk's Wegovy (active ingredient semaglutide) and U.S. Eli Lilly's Mounjaro (tirzepatide), both of which are glucagon-like peptide-1 (GLP-1) injectable medications. Patients must administer injections themselves once a week, which can be cumbersome.
Oral obesity medications can provide greater convenience for patients, potentially increasing market demand. Additionally, they can be produced in large quantities more easily than injectable treatments, reducing costs. Pen injectors are more than 10 times the unit price of standard syringes.
Currently, the only oral GLP-1 formulation is Rivalsus, developed by Novo Nordisk, which has only been approved as a treatment for diabetes. U.S. pharmaceutical company Amgen also attempted to develop an oral obesity drug but shifted its focus to developing Maritide, which is administered via injection once a month, after halting its oral obesity drug development last year.
Eli Lilly plans to announce phase 3 trial results for its oral obesity treatment, orforglipron, as early as the first half of this year. The previous phase 2 trial showed promising results, with a weight reduction rate of at least 10% by week 36 observed in 46-75% of the orforglipron group compared to 9% in the placebo group.
China's Hangzhou Jiuzhou Pharmaceutical is developing two oral obesity drug candidates through technology transfer at clinical phases 2 and 3 with U.S. Hercules CM Neucore.
Pfizer has announced that it will challenge the development of another class of oral obesity treatments. The company is developing an oral obesity treatment that inhibits glucose-dependent insulinotropic polypeptide receptor (GIPR). GIPR antagonists have the effect of promoting insulin secretion and preventing fat accumulation. It is known that they are currently analyzing data after completing phase 2 trials.
Domestic corporations are also developing obesity treatments as oral drugs, but they are at an earlier stage of development compared to foreign corporations.
Ildong Pharmaceutical is researching an oral drug 'ID110521156' utilizing low-molecular compounds, while D&D Pharmatech has been conducting phase 1 trials for 'DD02S' in collaboration with U.S. partner Metsera since November of last year. D&D Pharmatech is developing peptide-based oral obesity treatments. Peptides are substances that make up proteins.