Memorandum
The table below includes an overview of the NASH competitive landscape. It includes all companies we are aware of with NASH candidates in development, though we acknowledge that it may be incomplete. We will continuously update the table as timelines change. Clinical phases abbreviated as “P1-P4.”
|
Sponsor |
Drug Name |
Class |
Status |
Other Remarks |
|
Intercept Pharma |
Obeticholic acid |
FXR agonist |
NDA; P3 |
FDA issued CRL in June 2020; Company had October 2020 FDA meeting to clarify CRL; expects to refile NDA in 2021. REGNERATE and REVERSE trials in F1-F3 fibrosis/cirrhosis expected to complete Oct 2022 and June 2021, respectively |
|
AbbVie |
Cenicriviroc (CVC) |
CCR2/CCR5 inhibitor |
P3 |
AURORA trial in F2-F3 fibrosis, completion expected Oct 2021; Allergan acquired Tobira September 2016; AbbVie acquired Allergan May 2020 |
|
Madrigal |
MGL-3196 |
THR-β agonist |
P3 |
52-week Phase 3 trial announced March 2019 with scheduled completion end 2021. Phase 2 results announced May 2018. |
|
Galmed Pharma |
Aramchol |
Oral SCD1 modulator |
P3/4 |
Phase 3/4 study with primary completion date estimated June 2022. Announced ARMOR trial Sep 2019 Phase 2b results announced June 2018. |
|
Cirius |
MSDC-0602K |
Mitochondrial pyruvate carrier modulator/ insulin sensitizer |
P3 |
Positive phase 2b EMMINENCE trial announced Nov 2019; Significant improvements in metabolic endpoints; Non-significant improvement in liver histopathology. P3 not yet begun. |
|
Galectin Therapeutics |
GR-MD-02 |
Polysaccharide polymer that targets extracellular galectins |
P2b/3 |
P2b/3 trial began June 2020 with December 2023 completion date. Phase 2 trials in NASH cirrhosis and advanced fibrosis completed October 2017 and September 2016. |
|
Novartis |
LJN452 (tropifexor) |
FXR agonist |
P2/3 |
Safety study (LDL elevation) begun May 2020 and est end in March 2021; Phase 2 FLIGHT-FXR study was completed April 2020. |
|
Novo Nordisk |
Semaglutide |
GLP-1 agonist |
P2b |
Fast Track designation granted by FDA in 3Q20; Phase 3 in NASH expected to begin in 2021; Positive phase 2b multiple dose trial completed in 1Q20. |
|
Novartis/AbbVie |
Tropifexor/ Cenicriviroc |
FXR agonist + CCR2/5 |
P2b |
Phase 2b study expected completion September 2020. No results announced. |
|
Inventiva |
IVA337 |
Triple PPAR a/b/g agonist |
P2b |
Phase 2b safety and efficacy study completed March 2020; positive results announced June 2020. |
|
BMS |
BMS-986036 |
Pegylated FGF21 analog |
P2b |
Two phase 2 studies in F4 (completion expected Oct 2021) and F3 (completion expected December 2021); Phase 2a data presented at EASL 2017 |
|
NGM Biopharma |
NGM282 |
FGF19 agonist |
P2b |
Fibrosis effectiveness confirmed in Feb 2020 and Nov 2019. Multiple dose 2b ALPINE results expected 1H2021. Cirrhosis study commencing 2H20. |
|
Viking Therapeutics |
VK2809 |
Liver-selective thyroid beta receptor agonist |
P2b |
VOYAGE trial announced Dec 2019; expected completion Nov 2021; phase 2 results announced September 2018; |
|
Lilly |
Tirzepatide (LY3298176) |
GIP/GLP-1 agonist |
P2b |
|
|
Enanta Pharma |
EDP-305 |
FXR Agonist |
P2b |
Phase 2b to complete in December 2022; Positive phase 2a results announced September 2019; Fast Track designation in January 2017 |
|
Merck (from NGM Bio) |
MK-3655 (formerly NGM313) |
KLB-FGFR1c receptor complex agonist |
P2b |
Phase 2b study began November 2020, est completion February 2023 ; Merck optioned from NGM Bio in January 2019. |
|
Poxel |
PXL770 |
AMPK activator |
P2b |
Phase 2a STAMP-NAFLD reported December 2020 with 2b in 2021 planned; raise of €17.7 million to advance of PXL 770 (and 065) in NASH announced in May 2020. |
|
CymaBay Therapeutics |
Seladelpar |
PPARδ agonist |
P2b |
Clinical development for PBC resumed in July 2020; NASH on hold, with potential development in combination with partner. |
|
Akero Therapeutics |
efruxifermin (EXR, AKR-001) |
FGF21 analog |
P2a |
Phase 2b/3 planned for 1H 2021. Additional positive phase 2a data presented at The Liver Meeting 2020; Positive phase 2a histological results from BALANCED in July 2020; |
|
Terns |
TERN-101 |
FXR agonist |
P2a |
First patient dosed in phase 2a LIFT trial in July 2020; Phase 1 results that confirm safety and efficacy announced February 2020; Fast Track designation in October 2019; Acquired from Lilly in April 2018 |
|
89Bio |
BIO89-100 |
Long-acting glycopegylated FGF21 analog |
2a |
Positive topline phase 1b/2a results shared in September 2020. Positive preclinical data presented April 2019. |
|
HighTide Therapeutics |
HTD1801 |
P2a |
Positive topline results from phase 2a study announced in May 2020 |
|
|
Novo Nordisk/ Gilead |
Injectable Semaglutide + cilofexor + firsocostat |
GLP-1+ FXR agonist + ACC inhibitor |
P2a |
Mixed phase 2 results announced in November 2020; Partnership announced in April 2019 |
|
AZ |
cotadutide (MEDI0382) |
GLP-1/glucagon dual agonist |
P2a |
Safety/PD trial initiated in 3Q19. Expected completion May 2021. |
|
Axcella |
AXA1125 and AXA1957 |
Endogenous metabolic modulators |
P2a |
Positive phase 2a data for AXA1125 presented at The Liver Meeting 2020; Phase 2b trial planned |
|
Can-Fite |
Namodenoson (CF102) |
Adenosine A3 receptor agonist |
P2a |
Phase 2 trial results expected May 2020 |
|
Novartis |
LIK066 |
SGLT-1/SGLT-2 inhibitor |
P2a |
Completed Nov 2019; awaiting results |
|
Pfizer |
PF-06835919 |
Ketohexokinase (KHK) inhibitor |
P2a |
Phase 2 study with metformin in NASH/diabetes patients; expected completion April 2021. |
|
Hanmi |
HM151211 |
GLP-1/GIP/glucagon triple agonist |
P1 |
FDA Fast Track Designation granted in July 2020; Positive phase 1 data in February 2020 |
|
Lipocine |
LPCN 1144 |
Oral prodrug of bioidentical testosterone |
P1 |
Interim phase 2 results announced January 2019 |
|
AZ |
AZ 2693 (formerly IONIS-AZ6-2.5-LRx) |
PNPLA3 inhibitor |
P1 |
Added to AZ pipeline in 2Q19; Acquired from Ionis in April 2018 |
|
Allergan |
Evogliptin |
DPP-4 inhibitor |
P1 |
Acquired from Tobira Therapeutics September 2016; Phase 1 trial investigating evogliptin in combination with CVC initiated September 2016 |
|
Allergan |
AGN-242266 |
FXR agonist |
P1 |
Acquired from Akarna Therapeutics September 2016 |
|
Shire |
SHP626 |
Apical sodium bile acid cotransporter inhibitor |
P1 |
Phase 1 trial completed July 2015 |
|
Pfizer |
PF-06865571 |
DGAT2 inhibitor |
P1 |
New phase 1 trial launched May 2018, expected to complete February 2019; Prior phase 1 trial completed July 2017; Other phase 1 studies completed and ongoing in subjects with and without NASH |
|
Lilly |
Undisclosed |
GLP-1/glucagon dual agonist (oxyntomodulin analog) |
P1 |
Announced development for NASH in R&D update in May 2016; Advanced to phase 1 in 4Q16 |
|
GSK |
GSK3008356 |
DGAT-1 inhibitor |
P1 |
|
|
J&J |
JNJ-2463 |
CB1 inverse agonist |
P1 |
Phase 1 study underway according to J&J’s 2017 Pharmaceutical Business Review; Collaboration with BirdRock Bio |
|
Genentech |
BFKB8488A |
bispecific FGFR1/Klothoβ antibody |
P1 |
Completed recruiting for phase 1b (n = 136) trial Phase 1 study in NASH and type 2 diabetes recruiting, expected to complete June 2019 |
|
Arrowhead |
ARO-ANG3 |
Angiopoietin-like protein 3 inhibitor |
P1 |
Phase 1 study expected to complete December 2019; potential treatment for dyslipidemia and other metabolic diseases, including NASH |
|
GSK/Arrowhead |
ARO-HSD |
RNAi |
P1 |
Phase 1 study expected to complete in February 2022, topline results presented at The Liver Meeting establish proof-of-concept |
|
Novartis |
IFM-2427 |
NLRP3 inhibitor |
P1 |
Acquired from IFM Tre in April 2019 |
|
Novartis |
RLX030 |
Relaxin receptor |
Undisclosed |
Data expected to read out in 2019; Also in phase 3 for acute heart failure |
|
Merck/Hanmi |
Efinopegdutide (formerly JNJ-5111/ HM12525A ) |
GLP-1/glucagon dual agonist |
Undisclosed |
License agreement with Merck in August 2020 to commercialize in US and outside of Korea; Originally licensed to Janssen in November 2015, but returned development rights in July 2019 following subpar phase 2 results in obesity (with and without diabetes) |
|
Lynkogen/Alteogen |
Undisclosed |
Long-acting "GLP-1 fusion" combination therapies |
Undisclosed |
Partnership announced July 2018 |
Discontinued Candidates
|
Sponsor |
Drug Name |
Class |
Status |
Other Remarks |
|
Gilead |
Selonsertib (GS-4997) |
ASK-1 inhibitor |
P3 |
Removed from NASH pipeline in 2Q20; Missed primary endpoint in STELLAR 4 announced 1Q19; STELLAR 3 trial in F3 fibrosis missed endpoint June 2019 |
|
Gilead |
Simtuzumab |
LOXL2 monoclonal antibody |
P2 |
Discontinued 3Q16 |
|
AstraZeneca/Regulus Therapeutics |
AZD4076/RG-125 |
Anti-microRNA (anti-miR103/107 oligonucleotide) |
P2 |
AZ pulled out of partnership 2Q17; Phase 2 trial initiated 3Q16; Phase 1 trial completed December 2016 |
|
Pfizer |
PF-06667272 |
Myeloperoxidase Inhibitor |
P1 |
Discontinued 4Q17 |
|
Genfit |
Elafibranor (GFT505) |
Dual PPAR alpha/delta agonist |
P3 |
Program terminated in 2Q20; will continue in PBC; RESOLVE-IT in F1-F3 fibrosis failed phase 3 interim analysis in May 2020 |
|
Albireo |
Elobixitat |
Oral ileal bile acid transporter inhibitor |
P2a |
Discontinued August 2020 |
|
Pfizer |
PF-05221304 |
ACC inhibitor |
P2a |
Discontinued in October 2020; possible future combination product |