Diabetic Nephropathy Competitive Landscape – February 17, 2022

February 17, 2022 update: The most notable updates to the diabetic nephropathy landscape include the approval of Farxiga for CKD in several geographies and the approval of Kerendia for CKD associated with type 2 diabetes.

  • AZ’s SGLT-2 Farxiga (dapagliflozin): Based on positive DAPA-CKD results presented at ESC 2020, AZ’s SGLT-2 Farxiga (dapagliflozin) was approved for CKD, with or without diabetes, in the US in April 2021 and in the EU and Japan in August 2021. AZ’s 4Q21 update attributed Farxiga’s remarkable sales growth in part to this CKD indication, and management noted a China approval for CKD is expected during 2022.
  • Bayer’s Kerendia (finerenone): Based on positive results from the FIDELIO-DKD trial, Bayer’s Kerendia (finerenone) become the first approved non-steroidal mineralocorticoid receptor antagonist (MRA) in July 2021, which was followed soon after by a US launch in August 2021. Kerendia is still awaiting market authorization in the EU, which was submitted in November 2020, as well as approvals in Japan and China. In September 2021, Bayer initiated a phase 3 trial (FIND-CKD) investigating Kerendia in non-diabetic CKD, which is expected to complete December 2025.
  • Other notable updates include the June 2021 enrollment completion of the FLOW trial investigating Novo Nordisk’s GLP-1 semaglutide in CKD; Lilly’s planned initiation of a phase 2 trial investigating GIP/GLP-1 dual agonist tirzepatide in CKD; and AZ’s August 2020 initiation of a phase 2 trial investigating GLP-1/glucagon dual agonist cotadutide in CKD, which is set to complete in March 2022.  

The table below includes an overview of the diabetic nephropathy competitive landscape. It includes all companies we are aware of with diabetic nephropathy candidates in development, though we acknowledge that it may be incomplete. We will continuously update the table as timelines change.


Drug Name



Other Remarks


Invokana (canagliflozin)

SGLT-2 inhibitor


Black box amputation warning removed in August 2020; Novel renal indication approved by FDA in September 2019; CREDENCE renal outcomes trial stopped early after IDMC finds significant efficacy, results presented April 2019 and renal indication requested March 2019 (Identifier: NCT02065791)


Farxiga (dapagliflozin)

SGLT-2 inhibitor


Approved in EU and Japan for CKD, with or without diabetes, in August 2021; Approved in US for CKD, with or without diabetes, in April 2021; Granted Breakthrough Therapy designation by FDA in October 2020; Positive DAPA-CKD full results presented at ESC 2020; Positive topline results shared in July 2020; DAPA-CKD stopped early due to “overwhelming efficacy” in March 2020; Fast Track designation granted by FDA in August 2019; DAPA-CKD study in patients with CKD with or without diabetes expected to complete November 2020


Jardiance (empagliflozin)

SGLT-2 inhibitor

Phase 3

Fast Track designation in CKD granted by FDA in March 2020; EMPA-KIDNEY study in patients with CKD with or without diabetes underway, expected to complete in December 2022


Kerendia (finerenone)

Non-steroidal MRA (mineralocorticoid receptor antagonist)


Commercial launch ongoing; Phase 3 (FIND-CKD) trial in non-diabetic CKD initiated in September 2021, expected completion December 2025; Approved in US for CKD in T2D in July 2021; Positive FIGARO-DKD full results and FIDELITY pooled analysis presented at ESC 2021, positive topline results shared in May 2021; Submitted to EMA in November 2020; Positive FIDELIO-DKD full results presented at ASN 2020, positive topline results shared in July 2020; FIGARO-DKD and FIDELIO-DKD trials expected to complete in February 2020 and October 2019, respectively

Novo Nordisk



Phase 3

FLOW trial launched June 2019 in people with type 2 diabetes and chronic kidney disease, expected completion August 2024, completed enrollment June 2021

NIH/JDRF/other collaborators


Xanthine oxidase inhibitor

Phase 3

Marketed for gout; PERL diabetic nephropathy study in type 1 diabetes ongoing; Expected primary completion August 2019, but final completion set for December 31, 2021 (Identifier: NCT02017171), “active, not recruiting” as of December 2021



2-OG inhibitor

Phase 3 for anemia associated with CKD

CRL issued in August 2021; Received positive CHMP recommendation in June 2021; FibroGen admits to altering safety data in April 2021; Submitted to FDA by Fibrogen/AZ in December 2019; FDA filing planned for 1H19, pushed back from 2H18; Approved for patients on dialysis in Japan in November 2019, marketed by Astellas; Approved with national coverage in China for anemia in CKD/ESRD in August 2019, marketed by AZ/FibroGen; Met primary endpoint in OLYMPUS and ROCKIES trials

Daiichi Sankyo

Minnebro (esaxerenone)

Oral MR antagonist

Phase 3

No further updates in DKD as of February 2022; Positive topline results from phase 3 released November 2019, full results published December 2020; Phase 3 study initiated September 2017, expected to complete March 2021; Phase 2 study completed July 2016 



GLP-1/GIP dual agonist

Phase 2

In Lilly’s December 2021 Investor Community Meeting, management announced the planned initiation of a phase 2 mechanism of action study in CKD (TREASURE-CKD)

Vifor Pharma/ChemoCentryx)


CCR2 (chemokine receptor) agonist

Phase 2

CCX140 development discontinued in FSGS (rare kidney disease) in 1Q21, no updates given on CKD; Vifor Pharma and ChemoCentryx expand alliance to including CCX140 in December 2016, Vifor has option to develop and commercialize CCX140 in more prevalent forms of CKD; Positive topline results reported December 2014; company seeking partner before initiating phase 3



GLP-1/glucagon dual agonist

Phase 2

Phase 2 initiated in patients with CKD and type 2 diabetes in August 2020, expected completion March 2022



Uric acid reabsorption inhibitor (URAT-1)

Phase 2

Phase 2 in HFpEF initiated in May 2020, expected completion in April 2022; Phase 2 SAPPHIRE combination study with allopurinol in CKD and hyperuricaemia initiated in July 2019; Data from phase 2 with febuxostat shows rapid reduction in albuminuria for patients with CKD and type 2; Phase 2 completed in August 2018

Scohia Pharma/Takeda

Imarikiren/SCO-272 (fka TAK-272)

Direct renin inhibitor

Phase 2

Listed on pipeline, as of February 2022; Positive phase 2 results published in March 2019; Under development at Scohia Pharma since early 2017

Scohia Pharma


Enteropeptidase inhibitor

Phase 2

Japanese phase 2 initiated in June 2020

Goldfinch Bio


Peripherally restricted cannabinoid 1 (CB1) inverse agonist monoclonal antibody

Phase 1 for severe insulin resistant diabetic nephropathy

Phase 1 launched in May 2021

Novo Nordisk/Epigen


Lysophosphatidic acid 1 (LPA1) receptor antagonist


No updates as of February 2021; Novo Nordisk licensed candidate in May 2018

Discontinued Candidates


Drug Name



Other Remarks

Mitsubishi Tanabe Pharma


MR antagonist

Phase 2

Removed from company pipeline for diabetic nephropathy as of October 2021; Phase 2 in NASH completed in April 2019; Phase 2 results published in September 2020;

Reata/Kyowa Hakko Kirin

Bardoxolone methyl (RTA 402)

Inhibitor of inflammation

Phase 3

FDA submission in Alport syndrome slated for end of 2020;  Bardoxolone shifted to rare kidney diseases; Reata’s phase 3 BEACON trial terminated in October 2012 due to safety concerns

Vascular Pharma


Targets insulin-like growth factor-1 signaling pathway

Phase 2

No company news since 2019; Phase 2 completed in March 2017, no updates since; Vascular Pharma receives $9 million in Series A to support VPI-2690B in February 2015



Mesenchymal precursor cells

Phase 2

CKD indication appears to have been deprioritized; Phase 2 results released in October 2016; Trial completed (Identifier: NCT01843387); Discussing phase 3 design with FDA

Concert Pharmaceuticals


PDE (phosphodiesterase) inhibitor

Phase 2

Presumably discontinued in CKD; CTP-499 licensed to Processa Pharmaceuticals in March 2018, to be studied in Necrobiosis Lipodica; Did not meet primary endpoint in phase 2 trial, results released in April 2014; Successful end-of-phase 2 meeting in summer 2014; company seeking partner before initiating phase 3



Endothelin-receptor antagonist

Discontinued (Phase 3)

SONAR study began 2Q13, enrollment complete 3Q17, terminated 1Q18, results presented April 2019 (Identifier: NCT01858532)



ASK-1 inhibitor

Discontinued (Phase 2)

Trial ongoing; completion expected August 2016 (Identifier: NCT02177786). Discontinued 3Q16.


Baricitinib (LY3009104)

JAK1/JAK2 inhibitor

Discontinued (Phase 2)

Trial completed September 2014 (Identifier: NCT01683409). Discontinued 2Q16.



Oxidation inhibitor

Discontinued (Phase 3)

Company filed for bankruptcy 1Q16



PDE5 inhibitor

Discontinued (Phase 2)

Trial completed August 2013 (Identifier: NCT01200394). Management mentioned “encouraging” phase 2 data during 3Q14 earnings call. Discontinued 1Q16.



TGF-alpha/epiregulin monoclonal antibody

Discontinued (Phase 2)

Trial completed September 2015 (Identifier: NCT01774981). Discontinued 4Q15


Undisclosed biologic

Anti-VEGF-1 monoclonal antibody

Discontinued (Phase 1)

Discontinued 1Q16.