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

19 MARKETED DRUGS

22 PIPELINE DRUGS

29 RECENT EVENTS AND ANALYST OPINION
29 Veverimer for Renal Disease (February 25, 2021)
30 Veverimer for Renal Disease (December 8, 2020)
32 Veverimer for Renal Disease (October 20, 2020)
33 Farxiga for Renal Disease (August 30, 2020)
36 Veverimer for Renal Disease (August 21, 2020)
38 Farxiga for Renal Disease (July 28, 2020)
39 Veverimer for Renal Disease (July 14, 2020)
41 Farxiga for Renal Disease (March 30, 2020)

43 KEY UPCOMING EVENTS

44 KEY REGULATORY EVENTS
44 Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments
44 Fast-Track For Nefecon
44 Bayer’s Kerendia Brings New Mechanism To Cardiometabolic Space
44 FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy
45 Advicenne Hastens EU Approval For Sibnayal By Withdrawing Orphan Designation
45 AstraZeneca’s Farxiga Moves Into CKD – Regardless Of Diabetes Status
46 EU Accelerated Assessment Tracker
46 Reata Seeks Priority Review For Bardoxolone
46 New To The Review Queue
46 Farxiga BTD Rests On Renal Outcomes Trial DAPA-CKD

48 LICENSING AND ASSET ACQUISITION DEALS
48 Stada Partners With Calliditas On Novel Budesonide Formulation
48 Arch Gets Rights To Cilastatin From Telara
48 Chinook, Evotec Partner On CKD Precision Medicine
48 VTv Licenses Renal Disease Candidate To Anteris
49 Spectrum Licenses CKD Therapy To Unicycive

50 REVENUE OPPORTUNITY

51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events

56 BIBLIOGRAPHY

57 APPENDIX

LIST OF FIGURES
17 Figure 1: Trends in prevalent cases of chronic kidney disease, 2018–27
22 Figure 2: Overview of pipeline drugs for renal disease in the US
22 Figure 3: Pipeline drugs for renal disease, by company
23 Figure 4: Pipeline drugs for renal disease, by drug type
23 Figure 5: Pipeline drugs for renal disease, by classification
36 Figure 6: Farxiga for Renal Disease (August 30, 2020): Phase III – DAPA-CKD
39 Figure 7: Farxiga for Renal Disease (July 28, 2020): Phase III – DAPA-CKD
43 Figure 8: Key upcoming events in renal disease
51 Figure 9: Clinical trials in renal disease
51 Figure 10: Top 10 drugs for clinical trials in renal disease
52 Figure 11: Top 10 companies for clinical trials in renal disease
52 Figure 12: Trial locations in renal disease
53 Figure 13: Renal disease trials status
54 Figure 14: Renal disease trials sponsors, by phase

LIST OF TABLES
15 Table 1: Prevalent cases of chronic kidney disease, 2018–27
18 Table 2: Prevalent cases of chronic kidney disease, by stage, 2018
20 Table 3: Marketed drugs for renal disease
24 Table 4: Pipeline drugs for renal disease in the US
29 Table 5: Veverimer for Renal Disease (February 25, 2021)
31 Table 6: Veverimer for Renal Disease (December 8, 2020)
32 Table 7: Veverimer for Renal Disease (October 20, 2020)
33 Table 8: Farxiga for Renal Disease (August 30, 2020)
37 Table 9: Veverimer for Renal Disease (August 21, 2020)
38 Table 10: Farxiga for Renal Disease (July 28, 2020)
40 Table 11: Veverimer for Renal Disease (July 14, 2020)
41 Table 12: Farxiga for Renal Disease (March 30, 2020)
50 Table 13: Historical global sales, by drug ($m), 2016–20
50 Table 14: Forecasted global sales, by drug ($m), 2021–25