Pharmaceutical companies are intensifying research efforts in chronic kidney disease (CKD) with over 75 companies actively developing more than 80 pipeline therapies, according to a comprehensive 2025 pipeline analysis by DelveInsight.
The report highlights significant activity across all development stages, from preclinical research through Phase III clinical trials, reflecting the growing recognition of CKD as a major global health concern affecting millions worldwide.
Key Late-Stage Candidates Show Promise
Among the most advanced candidates, AstraZeneca's Baxdrostat has emerged as a potential breakthrough therapy. Currently in Phase III trials, this highly selective aldosterone synthase inhibitor works by blocking the final step in aldosterone biosynthesis, reducing sodium reabsorption and fluid retention. Preclinical studies in cynomolgus monkeys demonstrated significant reductions in aldosterone production, prompting advancement to human trials.
Novo Nordisk's Ziltivekimab represents another promising approach in late-stage development. This proprietary anti-interleukin-6 ligand monoclonal antibody targets residual inflammatory cardiovascular risk in patients with advanced CKD. The therapy aims to reduce major cardiovascular adverse events in CKD patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation, addressing a significant unmet need as these patients face high cardiovascular event rates with no approved preventive therapies.
Novel Mechanisms Being Explored in Mid-Stage Development
The mid-stage pipeline features several innovative approaches, including Boehringer Ingelheim's BI-685509, a novel soluble guanylate cyclase (sGC) activator currently in Phase II trials. Preclinical studies showed the compound reduced proteinuria and glomerulosclerosis in animal models of diabetic kidney disease while also demonstrating anti-fibrotic effects.
In March 2025, Boehringer Ingelheim initiated a study investigating BI 690517 in combination with empagliflozin for adults with CKD at risk of progression, including those with and without type 2 diabetes. The study accepts participants regardless of whether they are currently taking angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), or sodium-glucose cotransporter-2 inhibitors (SGLT2i).
Bayer has also entered the field with a Phase 2b dose-finding study for BAY 3283142, evaluating its efficacy and safety on top of standard care in reducing albuminuria in CKD patients.
Early-Stage Pipeline Shows Diverse Approaches
The early-stage pipeline demonstrates considerable diversity in therapeutic approaches. Regulus Therapeutics' RGLS8429, currently in Phase I trials, represents a novel oligonucleotide therapy designed to inhibit miR-17 and preferentially target the kidney. Preclinical models have shown improvements in kidney function, size, and disease severity markers.
Poxel SA is developing PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, currently in Phase I evaluation for autosomal dominant polycystic kidney disease (ADPKD).
Multiple Therapeutic Modalities Under Investigation
The CKD pipeline spans diverse therapeutic modalities, including small molecules, monoclonal antibodies, recombinant fusion proteins, peptides, polymers, and gene therapies. Administration routes vary from oral and intravenous to subcutaneous, parenteral, and topical applications, providing potential options for different patient needs.
Dr. Sarah Chen, nephrologist and clinical researcher not affiliated with the report, commented: "The diversity of mechanisms being explored is particularly encouraging. CKD is a complex condition with multiple underlying pathways, so having therapies that target different aspects of the disease could eventually lead to more personalized treatment approaches."
Significant Industry Investment
Major pharmaceutical companies are making substantial investments in CKD research, including AstraZeneca, Eli Lilly, Boehringer Ingelheim, Novartis, Bayer, and Novo Nordisk. Smaller biotechnology companies are also contributing innovative approaches, including Shandong Suncadia Medicine, AdAlta, Alebund Pharmaceuticals, SCOHIA PHARMA, DiaMedica Therapeutics, Regulus Therapeutics, and UnicoCell Biomed.
In March 2025, Novo Nordisk announced a study evaluating NNC0519-0130, a novel compound being tested against semaglutide and placebo in participants with CKD with or without type 2 diabetes who have overweight or obesity. The 43-week study aims to assess safety across different doses while evaluating potential improvements in kidney function.
Shandong Suncadia Medicine initiated a Phase II clinical study of HRS-1780 Tablets and Henagliflozin Proline Tablets for CKD treatment, employing a multicenter, randomized, double-blind, placebo-controlled, parallel design.
Addressing Unmet Needs in CKD Management
Despite advances in CKD management, significant unmet needs remain. Current treatments primarily focus on slowing disease progression rather than reversing kidney damage. The pipeline therapies aim to address these gaps by targeting novel pathways involved in CKD pathogenesis.
"The current standard of care for CKD, while helpful, doesn't address all aspects of the disease," explained Dr. Chen. "Many patients still progress to end-stage renal disease requiring dialysis or transplantation. These pipeline therapies could potentially offer new options to better manage the condition and improve outcomes."
Future Outlook
As these therapies progress through clinical development, the landscape of CKD management could significantly evolve in the coming years. The diverse approaches being explored suggest a future where treatment may be more tailored to specific CKD subtypes and individual patient characteristics.
Industry analysts anticipate that some of these therapies could reach the market within the next 3-5 years, potentially transforming the treatment paradigm for millions of CKD patients worldwide.
