The FDA on May 13th approved the dual GIP-GLP1-agonist Mounjaro® (tirzepatide) from Eli Lilly for diabetes following the completion of the SURPASS studies (e.g. SURPASS-2 NCT03987919).
Mounjaro® is administered as a weekly injection just like the GLP1-agonist Ozempic® (semaglutide) from Novo Nordisk for diabetes. The table below summarizes products from Eli Lilly and Novo Nordisk that have already been granted FDA approval or candidates still in the drug pipeline.
Semaglutide from Novo Nordisk has also been approved for obesity (Wegovy®) and an oral formulation for diabetes (Rybelsus®).
| Company | Drug | FDA approval | Administration | Indication |
| Novo Nordisk | Ozempic® | 2017 | Weekly Injection | Diabetes |
| Eli Lilly | Mounjaro® | 2022 | Weekly Injection | Diabetes |
| Novo Nordisk | Wegovy® | 2021 | Weekly Injection | Obesity |
| Eli Lilly | Tirzepatide | Phase 3 | Weekly Injection | Obesity |
| Novo Nordisk | Rybelsus® | 2019 | Daily Oral | Diabetes |
| Novo Nordisk | Semaglutide | Phase 3 | Daily Oral | Obesity |
| Novo Nordisk | Insulin Icodec | Phase 3 | Weekly Injection | Diabetes |
| Novo Nordisk | IcoSema | Phase 3 | Weekly Injection | Diabetes |
| Eli Lilly | Trulicity® | 2014 | Weekly Injection | Diabetes |
| Novo Nordisk | Victoza® | 2010 | Daily Injection | Diabetes |
| Novo Nordisk | Saxenda® | 2014 | Daily Injection | Obesity |
Phase 3
Eli Lilly has injected Tirzepatide for obesity in phase 3 (e.g. SURMOUNT-1 NCT04184622) and Novo Nordisk has oral Semaglutide for obesity in phase 3 (OASIS-1 NCT05035095).
Novo Nordisk had the long acting once-daily insulin Tresiba® approved in 2015 and now has the long acting once-weekly Insulin Icodec in phase 3. Novo Nordisk also has a combination drug of Semaglutide and Insulin Icodec – IcoSema – in phase 3; comparison with Insulin Icodec (COMBINE-1 NCT05352815), Semaglutide (COMBINE-1 NCT05259033) and Insulin Glargine + Insulin Aspart (COMBINE-3 NCT05013229).
Phase 2
Both companies have various candidates in phase 2 for the treatment of type 2 diabetes and obesity:
Eli Lilly – LY3437943 GGG (GIP/GLP-1/Glucagon) Tri-Agonist for the treatment of diabetes (NCT04867785) and obesity (NCT04881760).
Eli Lilly – LY3502970 (GLP-1 Receptor Non-peptide Agonist) for diabetes (NCT05048719) and obesity (NCT05051579).
Novo Nordisk – FDC Sema – OW GIP – A combination of semaglutide and novel GIP (NNC0480-0389?) intended for once-weekly treatment of diabetes – NCT05144984
Novo Nordisk – CagriSema in T2D – A combination of amylin analogue cagrilintide and GLP-1 analogue semaglutide intended for once-weekly treatment of diabetes – NCT04982575
Novo Nordisk – PYY 1875 – A novel analogue of the appetite-regulating hormone, PYY (NNC0165-1875), intended for once-weekly treatment of obesity – NCT04969939
Conclusions
The FDA will likely grant approval to Eli Lilly of injected Tirzepatide for obesity and to Novo Nordisk of oral Semaglutide for obesity, so the big difference between Novo Nordisk and Eli Lilly in the GLP-1 space going forward is that Novo Nordisk will be able to offer tablets, and Eli Lilly will only be able to offer subcutaneous administration. Going forward Novo Nordisk continues to look like the stronger competitor in both the diabetes and obesity arena, despite Eli Lilly securing FDA approval of Mounjaro® and also having SGLT2 and DPP4 anti-diabetic products.
