Entry of oral GLP-1 obesity drug imminent...Novo vs Lilly

Novo Nordisk applies for FDA approval... oral semaglutide drug shows weight loss effects

Lilly's completes Phase III trials on orforglipron... Viking, Ildong, and D&D Pharmatech also developing similar drugs

The launch of an oral GLP-1 class obesity drug is imminent.

 

Novo Nordisk recently completed a Phase III clinical trial for its oral obesity drug candidate and submitted a marketing authorization application to the U.S.

 

Food and Drug Administration (FDA).

 

Eli Lilly, a competitor of Novo Nordisk, is also developing an oral GLP-1 class drug candidate, orforglipron, as a successor to Zepbound.

 

Lilly has confirmed significant weight loss effects of its candidate in a Phase III clinical trial.

 

In addition, domestic and international pharmaceutical companies such as Viking Therapeutics, Ildong Pharmaceutical, and D&D Pharmatech are also actively developing oral GLP-1 drugs.

 

Novo and Lilly complete Phase III trials side by side

According to industry sources on the 28th, Novo Nordisk has completed a Phase III clinical trial for its oral semaglutide-based obesity drug candidate and recently submitted a marketing authorization application to the FDA.

 

The pharmaceutical industry has been racing to develop new formulations since GLP-1 class obesity treatments such as Saxenda, Wegovy, and Zepbound emerged as global blockbuster drugs.

 

The existing drug Saxenda requires once-daily administration, while Wegovy and Zepbound require weekly injections.

 

Oral formulations are expected to gain a competitive edge in terms of convenience of administration.

 

Novo Nordisk, which developed the oral diabetes drug Rybelsus containing semaglutide, has also begun developing an oral obesity drug.

 

In the OASIS1 clinical trial, which confirmed the weight-loss effect of oral semaglutide, a 50mg dose of the compound demonstrated a 15% reduction in body weight compared to placebo over 68 weeks.

 

This result was statistically significant compared to the placebo group, and adverse reactions were comparable to those observed in previous injectable clinical trials.

 

Novo Nordisk is also developing a combination oral formulation of GLP-1 and amylin analog to stay ahead of the competition.

 

According to clinical results disclosed to date, the average weight loss effect of this new drug candidate at week 12 was 12%.

 

Eli Lilly has also recently disclosed the results of a Phase III clinical trial for its oral GLP-1 agent.

 

Lilly's investigational drug, orforglipron, demonstrated simultaneous effects on HbA1c and weight loss.

 

In the Phase III clinical trial named ACHIEVE-1, orforglipron 36 mg (once daily) reduced HbA1c by an average of 1.5% over 40 weeks.

 

During the same period, the placebo group saw a reduction of only 0.1%.

 

Additionally, the orforglipron group showed an average weight loss rate of 7.9%, compared to 1.6% in the placebo group, demonstrating a significant difference.

 

In terms of safety, no significant adverse reactions were observed beyond the gastrointestinal side effects that are characteristic of GLP-1 class drug.

 

The rate of treatment discontinuation due to adverse effects was 8% in the orforglipron 36 mg group, higher than the 1% in the placebo group, but most were mild-to-moderate in severity.

 

No serious adverse reactions, such as liver toxicity, were reported.

 

Lilly is preparing to submit a marketing authorization application for the obesity indication of orforglipron by the end of this year, with the diabetes indication targeted for submission in 2026.

 

Lilly aims to shift the paradigm of the GLP-1 market, which has been dominated by injectable formulations, by leveraging orforglipron.

 

Lilly expects a strong response from the medical field, as orforglipron is an oral small molecule drug with manufacturing ease and supply flexibility.

 

In fact, Lilly has already invested billions of dollars in expanding its production infrastructure in the U.S.

 

since last year to prepare for the global launch of orforglipron.

 

Novo Nordisk and Lilly lead the oral obesity drug pathway, with Viking and Ildong among other domestic and international pharmaceutical companies in pursuit

Semaglutide-based obesity drugs

In addition to Novo Nordisk and Lilly, Viking Therapeutics, Ildong Pharmaceutical, and D&D Pharmatech are also actively developing oral GLP-1 drugs.

 

Viking Therapeutics recently announced the results of a Phase I clinical trial of VK2735, an oral candidate drug targeting GLP-1/ glucose-dependent insulinotropic polypeptide (GIP).

 

This study evaluated the safety and tolerability of VK2735 in healthy adults with a body mass index (BMI) of 30 kg/m² or higher, who received a single daily dose of VK2735 for 28 days.

 

The clinical results demonstrated encouraging safety and tolerability of VK2735 at a maximum daily dose of 40 mg.

 

In detail, VK2735 at 40 mg showed a maximum weight loss effect of 5.3% compared to baseline.

 

In terms of safety, all treatment-related adverse events reported in participants who received VK2735 were mild-or-moderate.

 

The majority (76%) were mild, and vomiting, one of the representative side effects of obesity drugs, was not reported.

 

Viking Therapeutics plans to confirm the potential of VK2735 through a Phase II clinical trial Yunovia, a new drug research and development subsidiary of the Ildong Pharmaceutical, is conducting a Phase I clinical trial on ID110521156, a new drug candidate in the GLP-1 receptor agonist class targeting metabolic diseases such as diabetes and obesity.

 

ID110521156 is a small molecule drug, and the company aims to develop it as an oral synthetic new drug for diabetes and obesity with distinct advantages over existing representative treatments, such as peptide injections, including superior productivity and excellent ease of use.

 

Previously, Yunovia confirmed the efficacy of its candidate’s insulin secretion and blood sugar control through preclinical efficacy and toxicity evaluations.

 

Its candidate also demonstrated superior safety compared to competing drugs in the same class and confirmed promising drug characteristics in the recently completed Phase I single-ascending dose (SAD) trial.

 

D&D Pharmatech is collaborating with U.S.-based Metsera on the development of an oral obesity drug.

 

Previously, Metsera entered into a technology transfer agreement with D&D Pharmatech in April 2023 to acquire the rights to 'DD02S,' an oral GLP-1-based peptide obesity treatment candidate, and 'DD03,' an oral GLP-1, GIP, and glucagon receptor triple agonist obesity treatment candiate.

 

The first patient dosing for a Phase I/II clinical trial on DD02S was completed in North America last November.

 

D&D Pharmatech confirmed that DD02S demonstrated more than 12.5 times higher absorption rate than the currently marketed oral GLP-1-based obesity treatment ‘Rybelsus (semaglutide)’ in preclinical studies.