Memorandum
- The table below includes an overview of the entire GLP-1 agonist competitive landscape, including mono-agonists (injectable and oral), dual agonists, and tri-agonists. It includes all the companies we are aware of with GLP-1 based agonists in development, though we acknowledge that it may be incomplete. We will continuously update the table as timelines change. Glucagon formulations under development for hypoglycemia rescue or for use in pumps can be found in our glucagon competitive landscape.
|
Company |
Product |
Status |
Timeline |
|
Lilly |
Tirzepatide (LY3298176) |
Phase 3 |
Phase 3 SURPASS program in T2D: SURPASS-1 published in June 2021, SURPASS-2 published in June 2021, SURPASS-3 (sub-analyses: SURPASS-3 CGM, SURPASS-3 MRI) published in August 2021, SURPASS-4 published in October 2021, and SURPASS-5 published in February 2022; FDA approved tirzepatide, under brand name Mounjaro, for glycemic management in adults with T2D in May 2022; SURMOUNT-1 published July 2022, achieving 22.5% weight loss in participants with obesity; SURPASS J-mono and SURPASS J-combo results published in The Lancet in August 2022; SURPASS-6 ongoing, expected completion November 2022; Initiation of SURMOUNT-MMO trial in 3Q22; Phase 3 SURMOUNT-5 head-to-head trial of tirzepatide vs semaglutide 2.4 mg announced 2Q22, to initiate in 2023; SURMOUNT-2 to complete in April 2023, SURMOUNT-3 and SURMOUNT-4 to complete in May 2023; Phase 2 NASH trial, SYNERGY-NASH, expected to complete in December 2023 |
|
Lilly |
Retratrutide |
Phase 2 |
Projected phase 2 results for the oral GLP-1/GIP/glucagon tri-agonist in T2D and chronic weight management shared in Lilly’s 2023 forecast call in December 2022; Lilly estimates retatrutide will achieve up to 22%-24% weight reduction over 48 weeks in chronic weight management and A1c reduction up to 2% and 15-17% weight reduction in T2D after 36 weeks; Phase 3 trial in chronic weight management to initiate in 2023; if successful, Lilly to submit approval by 2026 |
|
Lilly |
Orforglipron |
Phase 2 |
Topline phase 2 data for the oral GLP-1 in T2D shared in Lilly’s 2023 forecast call in December 2022; dose-dependent reduction in A1c up to 2.1% and weight reduction up to 9.6% after 26 weeks; potential for “best-in-class oral GLP-1”; Full phase 2 results to be presented at ADA 2023; Phase 3 studies in T2D and weight management to initiate in 1H23; if successful, Lilly will submit for both indications in 2025 and 2026, respectively. |
|
Lilly/Innovent |
Mazdutide (LY3305677) |
Phase 2 |
Phase 1 trial completed July 2021 showing 13% reduction in body weight; Positive topline phase 2 results in diabetes announced July 2022; A1c reductions up to 1.7% and body weight reductions up to 7%; trial to complete December 2022 |
|
OPKO Health |
OPK88003 (formerly TT401) |
Phase 3 |
Positive phase 2b topline results on dose escalation trial reported March 2019; Topline phase 2a results reported February 2016; Acquired from Transition Therapeutics by OPKO Health after Lilly terminated partnership agreement; A joint venture between OPKO Health and China-based LeaderMed Health Group to develop, manufacture, and commercialize OPK88003 announced September 2021; Phase 3 trials in diabetes and obesity to begin early 2023 |
|
AstraZeneca |
MEDI0382 (cotadutide) |
Phase 2 |
Phase 2b results from June 2021 showed increased satiety, reduced liver fat, and greater body weight reductions compared to liraglutide; Phase 2 trials in NASH and DKD completed in May 2021 and March 2022, respectively |
|
Pfizer |
PF-06882961 (danuglipron) |
Phase 2 |
Phase 1 trial of the twice-daily oral GLP-1 published June 2021, showing no clinically meaningful adverse events; Phase 2b trial completed July 2021, found to reduce A1c by 1.6%; Phase 2b trial in adults obesity ongoing, expected completion in 4Q23 |
|
Pfizer |
PF-07081532 |
Phase 1 |
Phase 1 trial of once-daily oral GLP-1 in T2D completed in June 2022, showing significant glycemic lowering; more data to be shared in EASD 2022 abstracts; Phase 2b trial in T2D and obesity initiated in November 2022; set to complete in 1Q24; Pfizer will choose one oral GLP-1 between danuglipron and PF-07081532 to advance to phase 3 in T2D and obesity |
|
Novo Nordisk |
NN9423 |
Phase 1
Discontinued |
Discontinued in 2Q20; Second phase 1 expected to complete September 2019, results expected 4Q19; Previous phase 1 trialcompleted August 2017 |
|
OPKO Health |
MOD-6031 (once-weekly) |
Possibly discontinued |
Phase 1 trial initiated February 2016 and completed December 2016; focused on an obesity indication, rather than a type 2 diabetes indication |
|
Novo Nordisk |
GG-co-agonist (NN9277) |
Discontinued |
Phase 1 terminated in August 2020 due to success of Ozempic and AM833; Phase 1 trial completed September 2017 |
|
Lilly |
Undisclosed (once-weekly) |
Phase 1 |
Advanced into phase 1 in 4Q16; Oxyntomodulin analog under development for type 2 diabetes and NASH; First announced in May 2016 R&D update |
|
Xenetic Biosciences |
PSA-Oxyntomodulin |
Phase 1 (possibly discontinued) |
Topline phase 1 results reported May 2014; Not currently listed in company’s pipeline |
|
Zealand Pharma and Boehringer |
BI 456906 |
Phase 2 |
Phase 1a completed February 2018, and Phase 1bcompleted April 2020, demonstrating safety, tolerability, and weight loss; Phase 2 trial in type 2 diabetes completed November 2021; Phase 2 trial in obesity expected to complete October 2022; Phase 2 trial in NASH recruiting, expected to complete March 2024 |
|
Novo Nordisk |
OG2023SC (NN9023) |
Discontinued – Phase 1 |
Discontinued in 3Q19 because of higher efficacy with enhanced oral semaglutide formulations; Phase 1 trial completed December 2018; Announced during 3Q18 update; Potential for lower dosing or higher efficacy vs. semaglutide |
|
AstraZeneca |
MEDI7219 |
Phase 1 Discontinued |
Phase 1 study terminated due to “company strategic reasons” |
|
Chugai and Lilly |
OWL833 (also known as LY 3502970) |
Phase 2 |
Internal readout in 2020 to inform potential phase 2 progression; Moved to phase 1 as of 2Q19; Licensed from Chugai in September 2018; Management reaffirms Lilly’s commitment at JPM 2018 and during 4Q18 call; Phase 1 trial in healthy participants completed February 2022; Phase 1 trial in obesity and overweight recruiting, expected to complete October 2022; Phase 2 trial in T2D expected to complete September 2022 |
|
Sanofi |
SAR441255 |
Discontinued in 3Q19 |
Discontinued in 3Q19; was to enter clinical development in 2019 per Sanofi's 4Q18 call; First mentioned during Q&A on 1Q18 call |
|
Zealand |
GLP-1/glucagon/GIP mono, dual, and triple agonist portfolio |
Preclinical |
Portfolio announced in 1Q18; Zealand alluded to an interest in incretin multi-agonists during Capital Markets Day 2017 |
|
Lilly |
Undisclosed long-acting once-weekly glucagon |
Preclinical |
|
|
Carmot Therapeutics |
Undisclosed |
Preclinical |
Phase 1 study in type 2 with overweight/obesity underway, in line with 2018 timing; Funding announced in January 2018 |
|
Janssen |
JNJ-54728518 |
Preclinical |
Data presented on ADA 2016 poster showing efficacy vs. Novo Nordisk’s Victoza (liraglutide) |
|
Pegbio |
PB-718 |
Preclinical |
Preclinical results presented at ADA 2017 |
|
Altimmune |
ALT-8010 (formerly SP-1373) |
Phase 1 |
Acquired from Spitfire Pharma July 2019; Preclinical results presented at ADA 2017; Phase 1 results showed average weight loss of 10% after 12 weeks on drug; completed October 2021 |
|
Adocia |
BioChaperone Glucagon GLP-1 (Exenatide) |
Preclinical |
Preclinical development announced January 2018; in-human trials to start 1H19 |
|
AstraZeneca |
G49 |
Preclinical |
Oxyntomodulin analog; Animal data presented at NASH Summit Europe 2017 |
|
J&J/Janssen |
JNJ-64565111 |
Discontinued |
License returned to Hanmi July 2019; Phase 2 trial in obesity launched April 2018, expected to complete March 2019; Phase 2 type 2 + obesity trial initiated July 2018; Phase 1b study in type 2 diabetes completed February 2018; Phase 1 resultspresented at ADA 2015; Preclinical data presented on ADA 2016 poster; Licensed from Hanmi November 2015 |
|
Sanofi |
SAR425899 |
Discontinued |
Discontinued in 4Q18 following phase 2 completion; Phase 3 trials in obesity originally slated to begin 2H18 but tolerability issues caused delays ahead of discontinuation; Phase 2 in type 2 diabetes completed December 2017; Promising phase 1 results presented at ADA 2016 |
|
Novo Nordisk |
Glucagon analog (G530L/NN9030) |
Discontinued |
Discontinued 2Q18; Announced in 3Q14; Completed phase 1 trial in July 2016; Currently positioned as an obesity therapy, and will possibly become a longer-acting formulation with the potential for co-formulation with a GLP-1 agonist. |
|
Novo Nordisk |
NNC9204-0530/liraglutide |
Discontinued |
Phase 1 trial initiated August 2016, completion expected July 2017 |
|
Zealand |
ZP2929 |
Discontinued |
BI dropped from partnershipJanuary 2014 due to preclinical toxicology results; Development paused in 3Q16 |
|
Novo Nordisk |
NN9709 |
Discontinued - phase 2 |
Added to pipeline in 4Q15 as part of Novo Nordisk’s acquisition of Dr. Richard DiMarchi’s (Indiana University, Bloomington, IN) companies Calibrium and MB2 in September 2015 (it’s possible that NN9709 is the same as Roche’s phase 2 GLP-1/GIP dual agonist RG7697, which was also developed with Dr. DiMarchi); Discontinued in August 2016 2Q16 update |
|
Roche |
RG7697 |
Discontinued - phase 2 |
Acquired from Marcadia in December 2010; Phase 1 study completed 4Q11; Phase 2 study initiated in 1Q15; Discontinued from pipeline in 2Q15 |
|
Sanofi |
SAR438335 |
Discontinued - phase 1 |
Discontinued in 4Q18; Announced in November 2015 Meet Sanofi Management meeting; Added to pipeline in 3Q15 |