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Drugmakers that have raked in billions from GLP-1s, such as Ozempic maker Novo Nordisk, are racing to figure out how to innovate as sales of the blockbuster drug start to slow.
The next big thing in the GLP-1 space will likely be more user-friendly versions of the drugs: oral pills, rather than the injectable formats popular weight loss drugs typically come in, Jayne Hornung, chief clinical officer at pharma consultancy MMIT, told Healthcare Brew.
“Patients always prefer an oral tablet over having to self-inject something, so I see this becoming the market leader in GLP-1s,” Hornung said.
Oral GLP-1s could also save patients money, as pills are generally cheaper to make than injectable drugs, according to Scientific American. However, “it’s all about supply and demand,” Hornung said. “I would hope that the pill would be cheaper, but [drugmakers are] going to price it according to market demands.”
Recent developments. Eli Lilly announced on April 17 positive results from a Phase 3 clinical trial of an oral GLP-1 called orforglipron, which the drugmaker is testing to treat both Type 2 diabetes and obesity.
Trial participants taking orforglipron lost on average 8% of their total body weight over 40 weeks, according to Eli Lilly. Comparatively, Lilly’s injectable obesity GLP-1, Zepbound, led to an average total body weight loss of 20.2% over 72 weeks in a separate Phase 3 trial, and its Type 2 diabetes GLP-1, Mounjaro, led to a mean total body weight loss of 26.6% over 84 weeks.
And Eli Lilly has already prepared to bring the oral GLP-1 drug to market, reporting in a 2024 SEC filing that it had stockpiled up to $548 million’s worth of orforglipron.
However, Novo breezed by Lilly when executives confirmed the company had submitted an application to the FDA “earlier this year” for approval of its own oral GLP-1, BioPharma Dive reported on April 21.
Novo executives announced in 2023 that a Phase 3 clinical trial of its oral semaglutide pill had shown strong results, with participants losing 15.1% of their body weight after 68 weeks. (Comparatively, a Phase 3 clinical trial of injectable semaglutide showed an average 14.9% body weight reduction after 68 weeks.)
Though Novo executives previously said they would file for FDA approval in 2023, spokesperson Jamie Bennett told Healthcare Brew the company decided to wait because it was “awaiting the results from the entire OASIS [Oral Semaglutide Treatment Effect in People with Obesity] program to include a full package for submission.” (OASIS is the name of Novo’s oral semaglutide clinical trials.)
Eli Lilly said in a statement the company plans to ask the FDA to approve its oral GLP-1 for weight loss treatment by the end of 2025 and as a Type 2 diabetes treatment in 2026.
On the flip side, Pfizer announced on April 14 it would discontinue developing its oral GLP-1 candidate, a once-a-day pill called danuglipron, because a clinical trial participant developed a potentially drug-induced liver injury. Pfizer previously tested a twice-daily version of danuglipron but discontinued that development as well, as gastrointestinal side effects were reported at high rates in Phase 2 trials.
With Novo and Lilly pulling a strong lead in the oral GLP-1 race, Hornung said she could see other manufacturers abandoning similar pursuits.
“A lot of the manufacturers see the writing on the wall that they won’t be the first to market and there’ll be a lot of competition, so they’ve opted to pull back on developing an oral GLP-1,” she said.