Tirzepatide offers indication-leading reductions in weight loss and improvements in glycemic control in a growing patient population, which has the potential to reduce the incidence of T2DM-related complications.
Also being studied to treat obesity and non-alcoholic steatohepatitis (NASH)
462 million people globally have T2DM
1.4% annual increase in drug-treated populations in G7 due to increasing rates of obesity and the aging population
Why is it a drug to watch?
A treatment that can more effectively address weight loss and glycemic control is of great interest. Tirzepatide will likely be prescribed for T2DM patients being acceptably managed with another drug or new patients who would benefit from weight loss.
Compared with other approved non-insulin T2DM therapies, large-scale SURPASS trials (>20,000 patients) have shown greater efficacy for:
• weight reduction and
• glycemic control.
Phase 3 SURPASS trials are ongoing, including a large CVOT (n=12,500) comparing the efficacy of tirzepatide with:
• placebo background therapy,
• TRULICITY® (dulaglutide) or
• OZEMPIC® (semaglutide).
Sufficient data, including regarding CV risk, are now available for regulatory submissions.
Eli Lilly and Company has a long history of bringing T2DM therapies to market.
Review and approval status
– New drug application (NDA) submitted to the FDA
– Marketing authorization application (MAA) submitted to the EMA Expected launch:
2022: United States
2023: Europe and Japan
Patents estimated to expire beginning in 2031
How will tirzepatide impact the market for type 2 diabetes?
It has demonstrated superiority over semaglutide (GLP-1 receptor agonist), which is the most efficacious noninsulin T2DM therapy currently available.
This could result in a significant market advantage over other therapies.
Strong uptake is anticipated due to the impressive weight loss and glycemic control data.
What gaps in treatment does tirzepatide fill?
Reducing body weight has become a focal point in T2DM management. Several antidiabetic agent classes are associated with no weight changes or even weight gain; only a handful offer weight loss. The net reduction provided by current agents is limited. With the promising results for both weight loss (clinically significant 15% weight loss) and glycemic control to date, tirzepatide could help delay disease progression and therefore the transition to insulin-based treatment.
What hurdles might it need to overcome to reach blockbuster status?
One concern in phase 2 trials was the large number of patients discontinuing tirzepatide because of gastrointestinal side effects; however, these subsided after time. Barriers to uptake, especially for patients who require less weight loss or glycemic control, could include the need for titration, availability of SGLT-2 inhibitors in generic formulations, competition from nearly as efficacious GLP-1 receptor inhibitors such as OZEMPIC® and RYBELSUS® and the high cost of tirzepatide.
Expected sales in 2026
probability of success for tirzepatide in the United States.
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of December 15, 2021
“It has amazing data regarding bigger HbA1c reductions and bigger reductions in weight, so it’s potentially a game-changer. It will need cardiovascular data since all the other drugs will have cardiovascular data, but it’s really promising.”
Drug Timeline & Success Rates
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021