CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND
8 Disease definition
8 Patient segmentation
9 Symptoms
9 Risk factors
9 Diagnosis

11 TREATMENT
11 Treatment of acute kidney injury
11 Treatment of chronic kidney disease

14 EPIDEMIOLOGY
14 Acute kidney injury
14 Chronic kidney disease (CKD)
14 Prevalence methodology

20 MARKETED DRUGS

23 PIPELINE DRUGS

30 RECENT EVENTS AND ANALYST OPINION
30 ANG-3777 for Renal Disease (December 9, 2021)
31 Imbarkyd for Renal Disease (December 8, 2021)
34 Veverimer for Renal Disease (February 25, 2021)
35 Veverimer for Renal Disease (December 8, 2020)
37 Veverimer for Renal Disease (October 20, 2020)

39 KEY UPCOMING EVENTS

40 KEY REGULATORY EVENTS
40 US FDA Turns Down Bardoxolone
40 EU Okay For Kerendia
40 US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
41 No Opinion For Finerenone
41 Nefecon Reverts To Standard Review in EU
42 Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments
42 Fast-Track For Nefecon
42 Bayer’s Kerendia Brings New Mechanism To Cardiometabolic Space
42 FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy
43 Advicenne Hastens EU Approval For Sibnayal By Withdrawing Orphan Designation
43 AstraZeneca’s Farxiga Moves Into CKD – Regardless Of Diabetes Status
43 EU Accelerated Assessment Tracker
44 Reata Seeks Priority Review For Bardoxolone

45 LICENSING AND ASSET ACQUISITION DEALS
45 CSL Makes $11.7bn Move On Vifor Pharma In Renal Disease Push
45 Chinook And Investor Syndicate Form Joint Venture in China
45 Vifor Bulks Up Renal Franchise With Sanifit And Inositec Acquisitions
46 Everest Partners On BTK Inhibitor With Sinovent, SinoMab
46 Kyowa Kirin Gains Japanese Rights To AM-Pharma’s Ilofotase
46 Vifor Clinches Deal For Travere’s Rare Kidney Disorder Drug
47 Stada Partners With Calliditas On Novel Budesonide Formulation
47 Arch Gets Rights To Cilastatin From Telara
47 Chinook, Evotec Partner On CKD Precision Medicine

48 REVENUE OPPORTUNITY

49 CLINICAL TRIAL LANDSCAPE
50 Sponsors by status
51 Sponsors by phase
52 Recent events

56 BIBLIOGRAPHY

57 APPENDIX

LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of chronic kidney disease, 2020–29
23 Figure 2: Overview of pipeline drugs for renal disease in the US
23 Figure 3: Pipeline drugs for renal disease, by company
24 Figure 4: Pipeline drugs for renal disease, by drug type
24 Figure 5: Pipeline drugs for renal disease, by classification
31 Figure 6: ANG-3777 for Renal Disease (December 9, 2021): Phase II – Post-Cardiac Surgery AKI Prevention (GUARD)
39 Figure 7: Key upcoming events in renal disease
49 Figure 8: Clinical trials in renal disease
49 Figure 9: Top 10 drugs for clinical trials in renal disease
50 Figure 10: Top 10 companies for clinical trials in renal disease
50 Figure 11: Trial locations in renal disease
51 Figure 12: Renal disease trials status
52 Figure 13: Renal disease trials sponsors, by phase

LIST OF TABLES
16 Table 1: Prevalent cases of chronic kidney disease, 2020–29
19 Table 2: Prevalent cases of chronic kidney disease, by stage, 2020
21 Table 3: Marketed drugs for renal disease
25 Table 4: Pipeline drugs for renal disease in the US
30 Table 5: ANG-3777 for Renal Disease (December 9, 2021)
32 Table 6: Imbarkyd for Renal Disease (December 8, 2021)
34 Table 7: Veverimer for Renal Disease (February 25, 2021)
36 Table 8: Veverimer for Renal Disease (December 8, 2020)
37 Table 9: Veverimer for Renal Disease (October 20, 2020)
48 Table 10: Historical global sales, by drug ($m), 2016–20
48 Table 11: Forecasted global sales, by drug ($m), 2022–26