Memorandum

GLP-1 Mono, Dual, and Tri-Agonist Competitive Landscape – January 24, 2020

  • 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 2020Phase 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 3Q16Phase 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 2019Phase 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