A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

Start Date05 Nov 2021

Sponsor / Collaborator

KBP Biosciences USA, Inc.

NCT04634812

/ CompletedPhase 1

A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects

This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.

Start Date03 Dec 2020

Sponsor / Collaborator

KBP Biosciences USA, Inc.

[+1]

NCT04606537

/ CompletedPhase 1

Phase 1, Open-label, Parallel, 2-arm, Fixed-sequence Study to Investigate the Effect of Coadministration of CYP3A4 Inhibitor and CYP3A4 Inducer on the Pharmacokinetics, Safety, and Tolerability of KBP-5074 in Healthy Subjects

Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in healthy male and female subjects.

Start Date24 Oct 2020

Sponsor / Collaborator

KBP Biosciences USA, Inc.

[+1]

100 Clinical Results associated with Ocedurenone

100 Translational Medicine associated with Ocedurenone

100 Patents (Medical) associated with Ocedurenone

Literatures (Medical) associated with Ocedurenone

01 May 2025·CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION

Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors

Review

Author: Hundemer, Gregory L. ; Helmeczi, Wryan

Purpose of review:

Aldosterone dysregulation plays a major role in the pathogenesis of hypertension, cardiovascular disease, and kidney disease. Traditionally, steroidal mineralocorticoid receptor (MR) antagonists, namely spironolactone and eplerenone, have been the only available options to target aldosterone. Over recent years, a host of promising novel aldosterone-targeted pharmacologic agents have been developed thereby providing new options to mitigate aldosterone-mediated cardiovascular and kidney disease.

Recent findings:

Recently, a number of nonsteroidal MR antagonists (finerenone, esaxerenone, and ocedurenone) and highly specific aldosterone synthase inhibitors (baxdrostat, lorundrostat, dexfadrostat, and vicadrostat) have been developed. The early clinical data for these novel medications looks promising regarding their efficacy in improving blood pressure control, preventing adverse cardiovascular outcomes, and slowing chronic kidney disease progression. Moreover, they appear to be generally safe and well tolerated.

Summary:

In the coming years, nonsteroidal MR antagonists and aldosterone synthase inhibitors are likely to play an increasingly large role in routine medical practice to help improve cardiovascular and kidney outcomes.

01 Mar 2025·Nefrologia

Evidence for the use of a nonsteroidal mineralocorticoid receptor antagonist for the treatment of chronic kidney disease

Review

Author: Avito Fernandes de Almeida, Edgar ; Marques da Silva, Bernardo ; Morais David Pliças, Mariana

INTRODUCTION AND OBJECTIVES:

Chronic kidney disease morbimortality drives the development of new drugs. This work summarizes the evidence on the use of non-steroidal mineralocorticoid receptor antagonists on chronic kidney disease.

MATERIALS AND METHODS:

A search was performed on PubMed and ClinicalTrials.gov using relevant keywords for clinical trials and observational studies, finished or ongoing, from 2019 to 2023.

RESULTS:

Finerenone is currently approved for diabetic kidney disease with albuminuria, with results from two phase three trials, presenting satisfactory results on renal and cardiovascular outcomes and an appropriate safety profile, namely regarding potassium balance. Regarding nondiabetic kidney disease, combining sodium glucose transport protein-2 inhibitors and finerenone points toward reliable results, although these came from non-placebo-controlled trials. An ongoing phase three trial is assessing finerenone efficacy and safety on nondiabetic chronic kidney disease. Esaxerenone is approved for diabetic nephropathies and hypertension in Japan, based on two phase three clinical trials. These trials' external validity is compromised, as they were only developed in Japan. Ocedurenone presents results from a phase two trial on managing refractory hypertension on chronic kidney disease. Apararenone is being investigated for diabetic kidney disease, with results from a phase two study, limited for only including Japanese patients.

CONCLUSIONS:

With this review we provide a global perspective on the available clinical results for these drugs to improve its evidence-based use.

01 Nov 2024·Heart (British Cardiac Society)

Diagnosis and management of resistant hypertension

Review

Author: Kreutz, Reinhold ; Cho, Myeong-Chan ; Camafort, Miguel

Resistant hypertension is a condition where blood pressure levels remain elevated above target despite changes in lifestyle and concurrent use of at least three antihypertensive agents, including a long-acting calcium channel blocker (CCB), a blocker of the renin-angiotensin system (ACE inhibitor or angiotensin receptor blocker) and a diuretic. To be diagnosed as resistant hypertension, maintaining adherence to therapy is required along with confirmation of blood pressure levels above target by out-of-office blood pressure measurements and exclusion of secondary causes of hypertension. The key management points of this condition include lifestyle changes such as reduced sodium and alcohol intake, regular physical activity, weight loss and discontinuation of substances that can interfere with blood pressure control. It is also recommended that current treatment be rationalised, including single pill combination treatment where antihypertensive drugs should be provided at the maximum tolerated dose. It is further recommended that current drugs be replaced with a more appropriate and less difficult treatment regimen based on the patient’s age, ethnicity, comorbidities and risk of drug–drug interactions. The fourth line of treatment for patients with resistant hypertension should include mineralocorticoid receptor antagonists such as spironolactone, as demonstrated in the PATHWAY-2 trial and meta-analyses. Alternatives to spironolactone include amiloride, doxazosin, eplerenone, clonidine and beta-blockers, as well as any other antihypertensive drugs not already in use. New approaches under research are selective non-steroidal mineralocorticoid receptor antagonists such as finerenone, esaxerenone and ocedurenone, selective aldosterone synthase inhibitors such as baxdrostat, and dual endothelin antagonist aprocitentan.

News (Medical) associated with Ocedurenone

29 Jul 2025

·www.novonordisk.com

Novo Nordisk lowers sales and operating profit outlook for 2025

Bagsværd, Denmark, 29 July 2025 – Novo Nordisk today announced sales and operating profit growth at constant exchange rates (CER) for the first six months of 2025 and updated full-year sales and operating profit outlook at CER. In the first six months of 2025, Novo Nordisk’s sales increased by 18% and operating profit increased by 29%, both at CER. Sales growth in the first six months of 2025 was positively impacted by gross-to-net sales adjustments related to prior years, including an adjustment related to the 340B provision of around DKK 3 billion in the second quarter of 2025. Operating profit growth is positively impacted by the ocedurenone impairment in the second quarter of 2024, partially countered by impacts related to the acquisition of the three Catalent manufacturing sites. Novo Nordisk has updated the full-year outlook for 2025, with sales growth now expected to be 8-14% and operating profit growth expected to be 10-16%, both at CER. Sales and operating profit growth reported in Danish kroner is now expected to be 4 and 7 percentage points lower than at CER, respectively, primarily due to depreciation of the USD/DKK exchange rate 1 . The lowered sales outlook for 2025 is driven by lower growth expectations for the second half of 2025. This is related to lower growth expectations for Wegovy ® in the US obesity market, lower growth expectations for Ozempic ® in the US GLP-1 diabetes market, as well as lower-than-expected penetration for Wegovy ® in select IO markets. For Wegovy ® in the US, the sales outlook reflects the persistent use of compounded GLP-1s, slower-than-expected market expansion and competition. Despite the expiry of the FDA grace period for mass compounding on 22 May 2025, Novo Nordisk market research shows that unsafe and unlawful mass compounding has continued, and that multiple entities continue to market and sell compounded GLP-1s under the false guise of ‘personalisation’. Novo Nordisk is pursuing multiple strategies, including litigation, to protect patients from knockoff ‘semaglutide’ drugs. Novo Nordisk is deeply concerned that, without aggressive intervention by federal and state regulators and law enforcement, patients will continue to be exposed to the significant risks posed by knockoff ‘semaglutide’ drugs made with illicit or inauthentic foreign active pharmaceutical ingredients. As unsafe and unlawful mass compounding continues, the Wegovy ® penetration within the cash channel has been lower-than-expected. Within this channel, NovoCare ® Pharmacy was launched in March 2025. Wegovy ® prescriptions via NovoCare ® Pharmacy (including TeleHealth collaborations) amount to around 11,000 total weekly prescriptions, in addition to around 20,000 weekly prescriptions in the retail cash channel. Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives such as NovoCare ® Pharmacy and further collaborations with telehealth organisations. Within the insured channel, despite the initiation of new commercial activities of Wegovy ® in the first half of 2025, the sales outlook also reflects lower-than-expected penetration for Wegovy ® , mainly due to slower market expansion and competition. Novo Nordisk continues to engage in additional commercial initiatives and expects a regulatory decision around the Wegovy ® MASH indication during the second half of 2025. Moreover, Novo Nordisk continues to expect a positive contribution from changes to the CVS national template formulary effective 1 July 2025, where Wegovy ® is now the only GLP-1 medicine covered for obesity. For Ozempic ® , the updated outlook is negatively impacted by competition in the US. Novo Nordisk continues to invest in commercial activities and label updates towards driving further market penetration of Ozempic ® . Finally, while IO Wegovy ® sales are growing at high rates and launches are progressing, the sales outlook reflects lower-than-expected penetration for Wegovy ® in select IO markets due to slower market expansion and competition. With around 1 billion people living with obesity globally and only a few million on treatment, the outlook reflects a continued global rollout of Wegovy ® to more markets. The updated expectation for operating profit growth reflects the lower sales growth outlook, partially countered by reduced spending. A negative mid-single-digit operating profit growth impact related to the acquisition of the three former Catalent manufacturing sites remains included in the guidance. Novo Nordisk now expects financial items (net) for 2025 to amount to a gain of around DKK 3 billion. This is mainly driven by expected gains on hedged currencies, primarily the US dollar, partially offset by interest expenses related to funding of the debt-financed Catalent transaction. Finally, the free cash flow is now expected to be DKK 35-45 billion, reflecting the lower-than-planned expected sales growth, mainly driven by lower volume growth of GLP-1-based treatments in the US and related cash flow implications amplified by the US gross-to-net system. Novo Nordisk’s full disclosure of the financial results for the first six months of 2025 will be published on 6 August 2025, where more information will be available. The above expectations are based on additional assumptions, including assumptions described on pages 14 and 15 of the Financial report for the first three months of 2025 (Company Announcement No 14/2025). The forward-looking statements on page 23 in the Financial report for the first three months of 2025 (Company Announcement No 14/2025) also apply to this company announcement. Conference call Novo Nordisk will host a conference call for investors at 14.30 CEST on 29 July 2025, corresponding to 8.30 am EST. For more information on how to listen, please visit the investor section of novonordisk.com. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information Publication of inside information pursuant to Market Abuse Regulation, Article 17 1 Based on exchange rates of 23 July 2025 with e.g. a USD/DKK spot rate of 635. Full currency overview to be released as part of Novo Nordisk’s full disclosure of the financial results on 6 August 2025 Company announcement No 18 / 2025

Financial Statement

21 Feb 2025

·www.fiercepharma.com

Fierce Pharma Asia—Novo Nordisk's fraud accusation; AstraZeneca's China deal; Ono's FDA nod

Novo Nordisk's dealmaking dispute with KBP Biosciences, AstraZeneca's purchase of FibroGen China and Ono's FDA approval for a rare tumor drug made our news this week. Novo Nordisk alleges Singaporean biotech KBP Biosciences made misleading statements before the two firms inked a licensing deal worth up to $1.3 billion. AstraZeneca is buying out its roxadustat partner FibroGen in China. Ono Pharmaceutical's $2.4 billion Deciphera acquisition has borne fruit. And more.1. Novo Nordisk to sue KBP Biosciences over alleged fraudulent claims on kidney disease drugNovo Nordisk is alleging that KBP Biosciences intentionally withheld negative clinical data before the Danish company bought the latter’s hypertension candidate ocedurenone in a potential $1.3 billion deal in 2023. Novo plans to seek $830 million in damages from the Singaporean biotech, which was founded by Huang Zhenhua in China. The Singapore International Commercial Court has ordered a freeze of the assets of KBP and Huang as Novo prepares to launch arbitration proceedings in New York.2. AstraZeneca pays $160M for FibroGen's China unit, regional rights to roxadustatAfter ditching FibroGen’s chronic kidney disease drug roxadustat in the U.S., AstraZeneca has decided to take full control of the HIF-PH inhibitor in China. The British pharma is paying $160 million to buy FibroGen’s China unit. Last year, AZ recorded $336 million in revenue from the drug, sold as Evrenzo in China, a 22% increase despite generic competition.3. FDA approves Ono's rare tumor drug from $2.4B Deciphera buyoutOno Pharmaceutical’s Deciphera Pharmaceuticals has won FDA approval for Romvimza as a competitor to Daiichi Sankyo’s Turalio in symptomatic tenosynovial giant cell tumor. The Japanese pharma bought the U.S. biotech last year for $2.4 billion to expand its targeted oncology portfolio and boost its U.S. footprint. Compared with Turalio, Romvimza holds a convenience edge and does not come with a black box warning.4. Otsuka breaks up with cancer candidates on strategic groundsOtsuka has nixed several clinical cancer programs for “strategic reasons.” Among the candidates, the only one that the company was developing in the U.S. was OPB-111077, an oral STAT inhibitor that entered the clinic in 2012. The drug was mostly recently tested in a lymphoma trial starting in 2019 until enrollment stopped last year. The other three are being tested only in Japan.5. Siemens Healthineers plans 'mega depots' to bolster US supply chain amid 'geopolitical uncertainties'As President Donald Trump’s new tariffs on China and Mexico are expected to impact medical devices, Siemens Healthineers said it’s building new “mega depots” for spare parts and other inventory in New York City and Oakland, California. The company cited “geopolitical uncertainties” as a potential threat to a stable medtech supply chain.6. Radiance rolls into ROR1 race, paying $15M for ADC rival to Merck’s frontrunnerRadiance Biopharma is paying $15 million upfront for rights to a ROR1-directed antibody-drug conjugate from a subsidiary of China’s CSPC Pharmaceutical. The deal could be worth more than $1 billion if the drug reaches certain sales milestones. After reporting a 100% complete response rate, Merck & Co. has moved its ROR1 ADC into phase 3 testing in diffuse large B-cell lymphoma.Other News of Note: 7. Amid Merck supply squeeze, ImmunityBio and Serum Institute snag FDA blessing for BCG expanded access program8. Ascletis' swift surge into obesity continues with competitive oral GLP-1 data9. FDA hits pair of Indian API makers with warning letters, import alerts

Drug ApprovalAcquisitionLicense out/inPhase 3ADC

18 Dec 2024

·www.fiercebiotech.com

Novo Nordisk taps Photys for $186M cardiometabolic collab

Photys Therapeutics is on deck to tackle preclinical efforts, while Novo Nordisk is slated to take the potential assets through IND-enabling studies and clinical development. \n With Novo Nordisk’s name already synonymous with treatments for diabetes and obesity, the Danish drugmaker has been making a concerted push to bolster its pipeline beyond GLP-1 stalwarts Ozempic and Wegovy, branching out into other cardiometabolic conditions like metabolic dysfunction-associated steatohepatitis (MASH) and chronic kidney disease (CKD).Now, as part of that development odyssey, the company is tapping into an emerging protein technology from Photys Therapeutics.Under a new research collaboration unveiled Wednesday, Novo will pay Photys up to $186 million in upfront, development and commercial milestone payments to help develop proximity-based therapeutics for an unnamed cardiometabolic disease target.The deal—which will also see Photys receive R&D funding and potential tiered royalties on commercial sales—hinges on the biotech’s Phosphorylation Inducing Chimeric Small molecules (PHICS) technology. The company has designed its proprietary platform to induce proximity between a kinase and a protein of interest in order to phosphorylate that target and change its biologic function, Photys explained in a release.Novo and Photys plan to work together on multiple PHICS molecules for their chosen cardiometabolic target. Photys is on deck to tackle preclinical efforts, while Novo is slated to take the potential assets through investigational new drug-enabling studies and clinical development, the partners said.“This collaboration represents a strong alignment between the desire to control a critical protein and a technology capable of doing so in a tissue-specific manner,” Alexandra Joseph, Ph.D., Photys’ chief scientific officer, said in a statement.Meanwhile, Novo’s corporate vice president and therapeutic area head of diabetes, obesity and MASH, Bei Zhang, Ph.D., said the deal could allow her company to reach important protein targets “with a high degree of efficacy and selectivity.” Photys, which is based right next to Boston in Waltham, Massachusetts, uncloaked in 2022 with $75 million in funds from Merck & Co.’s MRL Ventures Fund, Eli Lilly, Arkin Bio and Mass General Brigham Ventures, among others.The biotech has stayed relatively quiet over the last two years, with the October appointment of Joseph the most recent update on the company’s website.Novo Nordisk, for its part, has been working hard to enrich its cardiometabolic pipeline in areas beyond diabetes and obesity, where the company currently dominates the commercial market with its respective GLP-1 medicines Ozempic and Wegovy.So far, the company’s success has been somewhat mixed.Back in May, Novo unveiled full results from its FLOW trial showing that a once-weekly 1-mg dose of semaglutide—the molecule behind Ozempic and Wegovy—helped combat major kidney outcomes like kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and CKD.At the time, Novo’s executive medical director, Michael Radin, M.D., told Fierce Pharma the results could “really move the needle” and set a new standard for “holistic” care for many patients living with both diabetes and kidney disease.Additionally, 2.4-mg semaglutide recently excelled in a phase 3 study of MASH patients, prompting Novo to ready filings for submission to regulators in Europe and the U.S. in the first half of 2025. Still, Novo has been less fortunate with external cardiometabolic efforts, as evidenced by the drugmaker’s decision in early November to scrap a late-stage kidney drug acquired through a $1.3 billion deal with KBP Biosciences.Novo had hoped the CKD prospect, dubbed ocedurenone, could eventually rival Bayer’s Kerendia. But those hopes were dashed when the nonsteroidal mineralocorticoid receptor antagonist missed its primary endpoint at the time of a prespecified interim analysis. With ocedurenone gone, the only CKD program still listed in Novo’s pipeline is semaglutide.

Phase 3Executive Change

100 Deals associated with Ocedurenone

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	United States	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	China	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Australia	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Bosnia and Herzegovina	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Bulgaria	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Canada	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Croatia	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Czechia	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Georgia	KBP Biosciences USA, Inc.	05 Nov 2021
Chronic Kidney Diseases	Phase 3	Germany	KBP Biosciences USA, Inc.	05 Nov 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04968184 (CLARION-CKD, NEWS) Manual	Phase 3	Hypertension \| Chronic Kidney Diseases	600	ocedurenone	iqpwbewpuf(acascgxtqy) = failed to meet its primary endpoint trjvbqwdcx (cabuoiiisl ) Not Met	Negative	27 Jun 2024
NCT04534699 (KBP-5074, Pubmed \| Eur J Drug Metab Pharmacokinet)	Phase 1	Hepatic Insufficiency	-	Ocedurenone 0.5 mg	ctdthpvcbv(twwgbcksfb) = cygqrwzemv vxasdidtsz (ewqkvybklb ) View more	-	01 Mar 2024
				Placebo	ctdthpvcbv(twwgbcksfb) = aimdrttisu vxasdidtsz (ewqkvybklb ) View more
NCT03574363 (BLOCK-CKD, Pubmed \| Hypertension)	Phase 2	Chronic Kidney Diseases	162	Placebo	tityhwuguh(rdqqquvuaz) = rspgsqqvpw bzumdrrfhg (iwecctjvqa )	Positive	01 Jul 2021
				KBP-5074 0.25 mg	tityhwuguh(rdqqquvuaz) = wboyjwfmio bzumdrrfhg (iwecctjvqa )
NCT02837237 (CTgov)	Phase 1	Kidney Failure, Chronic \| Chronic Kidney Diseases	11	KBP-5074	dnaefciclb = rkdevbszxh cdeloaznym (qcqgvoztdp, nkoaqlimwm - vfzqcohlab) View more	-	15 Oct 2019
ASN2017	Phase 1	Chronic Kidney Diseases	11	KBP-5074 0.5 mg	diisfrfnib(nrbjzfaixm) = bcxkuqzlsp opdainnteb (uqobkcbcfj ) View more	Positive	31 Oct 2017
				KBP-5074 (Hemodialysis)	diisfrfnib(nrbjzfaixm) = ubkyotbwnh opdainnteb (uqobkcbcfj ) View more

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