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 |
Class |
Product |
Status |
Timeline |
|
Lilly |
GIP/GLP-1 |
Tirzepatide (LY3298176) |
Phase 3 |
Phase 3 SURPASS program in type 2 to complete in 2021, regulatory submission expected in 2022; Phase 3 SURMOUNT-1 in obesity expected to complete February 2022; Phase 2 SYNERGY-NASH in NASH expected to complete March 2022; Phase 2 data presented at EASD 2018; Phase 1 trial completed June 2017 |
|
OPKO Health |
Glucagon/GLP-1 |
Oxyntomodulin OPK88003 (formerly TT401) |
Phase 2 |
"Poised for phase 3" according to OPKO website; Positive phase 2b topline results reported March 2019; Topline phase 2a results reported February 2016; Acquired from Transition Therapeutics by OPKO Health after Lilly terminated partnership agreement; OPKO Health focused on an obesity indication, rather than a type 2 diabetes indication |
| Pfizer | Oral GLP-1 (small molecule) | PF-06882961 | Phase 2 |
Phase 2 in type 2 expected to complete April 2021, posted June 2019 |
| Hanmi | GLP-1/GIP/glucagon tri-agonist | LAPSTriAgonist | Phase 2 | Phase 2 in NASH expected to initiate in 2Q20, as per JPM 2020 |
|
Novo Nordisk |
Tri-agonist |
NN9423 |
Phase 1 | Second phase 1 in people with overweight or obesity expected to complete September 2019, results expected in 4Q19; Previous phase 1 trial completed August 2017 |
| Novo Nordisk | Glucagon/GLP-1 | GG-co-agonist (NN9277) | Phase 1 | Phase 1 study now expected to complete May 2019 (pushed back from December 2018); Previous phase 1 trial completed September 2017 |
|
Lilly |
Glucagon/GLP-1 |
Undisclosed (once-weekly) |
Phase 1 |
Advanced into phase 1 in 4Q16; First announced in May 2016 R&D update; Oxyntomodulin analog under development for type 2 diabetes and NASH |
|
Zealand/BI |
Glucagon/GLP-1 |
BI 456906 |
Phase 1 |
Phase 2 expected to initiate in February 2020; Phase 1b study initiated August 2018, results expected 1H19; Phase 1 safety and tolerability study completed February 2018, results expected in 2H18; Candidate selected 3Q15; In development for obesity and type 2 diabetes |
| AZ | Reportedly oral GLP-1 | MEDI7219 | Phase 1 | Added to pipeline in 1Q18; Phase 1 study expected to complete April 2020, pushed back from October 2018, then March 2019 |
| Lilly | Oral GLP-1 (small molecule) | OWL833 | Phase 1 | 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 |
|
Xenetic Biosciences |
Glucagon/GLP-1 |
PSA-Oxyntomodulin |
Phase 1 (possibly discontinued) |
Topline phase 1 results reported May 2014; Not currently listed in company’s pipeline |
|
OPKO Health |
Glucagon/GLP-1 |
MOD-6031 (once-weekly) |
Phase 1 (Possibly discontinued) |
Last mentioned in 3Q16; Phase 1 trial initiated February 2016, completion expected December 2016; OPKO Health focused on an obesity indication, rather than a type 2 diabetes indication |
| Novo Nordisk | Oral GLP-1 (peptide) | OG2023SC (NN9023) | Discontinued in 3Q19; Previously in phase 1 | Discontinued in 3Q19 because of higher efficacy with enhanced oral semaglutide formations; Phase 1 trial completed December 2018; Announced during 3Q18 update; Potential for lower dosing or higher efficacy vs. semaglutide |
| Sanofi | Tri-agonist | 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 | Tri-agonist | 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 |
Glucagon |
Undisclosed long-acting once-weekly glucagon |
Preclinical |
Announced in May 2016 R&D update; Potential for co-formulation with GLP-1 agonist Trulicity (dulaglutide) or with GIP/GLP-1 dual agonist |
| Carmot Therapeutics | GIP/GLP-1 | Undisclosed | Preclinical | Phase 1 study in type 2 with overweight/obesity underway, in line with 2018 timing; Funding announced in January 2018 |
|
Janssen |
Glucagon/GLP-1 |
JNJ-54728518 |
Preclinical |
Data presented on ADA 2016 poster showing efficacy vs. Novo Nordisk’s Victoza (liraglutide) |
|
Pegbio |
Glucagon/GLP-1 |
PB-718 |
Preclinical |
Preclinical results presented at ADA 2017 |
|
Altimmune |
Glucagon/GLP-1 |
ALT-801 (formerly SP-1373) |
Preclinical |
Acquired from Spitfire Pharma July 2019; Planned advance to clinic in 2020; Preclinical results presented at ADA 2017 |
| Adocia | Glucagon/GLP-1 | BioChaperone Glucagon GLP-1 (Exenatide) | Preclinical |
Preclinical development announced January 2018; in-human trials to start 1H19 |
| AstraZeneca (MedImmune)
|
Glucagon/GLP-1 |
G49 |
Preclinical |
Oxyntomodulin analog; Animal data presented at NASH Summit Europe 2017 |
|
J&J/Janssen |
Glucagon/GLP-1 |
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 | Glucagon/GLP-1 | 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 |
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 |
Glucagon/GLP-1 |
NNC9204-0530/liraglutide |
Discontinued |
Phase 1 trial initiated August 2016, completion expected July 2017 |
|
Zealand |
Glucagon/GLP-1 |
ZP2929 |
Discontinued |
BI dropped from partnership January 2014 due to preclinical toxicology results; Development paused in 3Q16 |
| Novo Nordisk | GIP/GLP-1 | 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 | GIP/GLP-1 | 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 | GIP/GLP-1 | SAR438335 | Discontinued - phase 1 | Discontinued in 4Q18; Announced in November 2015 Meet Sanofi Management meeting; Added to pipeline in 3Q15 |