A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Baxdrostat on Ambulatory Blood Pressure in Chinese Participants With Uncontrolled Hypertension on Two or More Antihypertensive Medications Without Diuretics

This is a Phase IIIb, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN.
Consenting participants will be screened within 4 weeks and will subsequently enter a 4-week run-in period with placebo. Thereafter, participants will be randomised in a 1:1 ratio to receive one of the following 2 treatments QD, during a 12-week double-blind treatment period:
baxdrostat 2mg Placebo The randomisation will be stratified by mean ambulatory SBP at baseline (<140 mmHg, ≥140 mmHg) and the number of background antihypertensive medication classes (2, ≥3) at baseline.
During the 12-week double-blind treatment period, participants should remain on their background antihypertensive medication. Doses of background medications should not be changed during this period unless participants experience SBP < 100 mmHg with symptoms of hypotension. Rescue therapy is permitted if the SBP or DBP exceeds 170 or 105 mmHg, respectively. The choice of rescue therapy is based on the Investigator's best clinical judgement; however, the use of potassium-sparing diuretics and MRAs are prohibited.After completing the 12 weeks double-blind treatment period participants will complete a 2-week safety follow-up period. The total duration of study participation will be of approximately 22 weeks.

Start Date17 Sep 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT07800858

/ Not yet recruitingNot ApplicableIIT

Effects of aLdosterone Inhibition by baXdrostat on Molecular Imaging of cytoReduction in Primary Aldosteronism and Hypertension

The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment.
Participants will receive baxdrostat for 24 weeks and will be followed for changes in their adrenal imaging, blood pressure and hormone levels. The study will also investigate whether changes caused by treatment continue after baxdrostat is stopped.
This is a single-group study, meaning that all participants receive baxdrostat and there is no placebo or comparison group.

Start Date15 Sep 2026

Sponsor / Collaborator

Queen Mary University of London

[+1]

NCT07655362

/ Not yet recruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling

The goal of this trial is to learn whether adding the blood pressure medication baxdrostat (Baxfendy) to standard-of-care medical therapies will beneficially change the heart structure and function of adults who have high blood pressure, thickened left heart walls, and are at risk for heart or kidney disease.
To determine if baxdrostat improves heart structure and function, the participants will:
* take a baxdrostat or a placebo (a look-alike tablet that contains no drug) tablet once a day for 12 months
* undergo a safe and non-invasive cardiac magnetic resonance imaging scan (to measure heart mass, stiffness and function) at the beginning of the study and 12 months later
* visit the clinic for checkups and blood or urine tests 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after taking the first tablet

Start Date30 Jun 2026

Sponsor / Collaborator

Canadian Medical and Surgical Knowledge Translation Research Group

[+1]

100 Clinical Results associated with Baxdrostat

100 Translational Medicine associated with Baxdrostat

100 Patents (Medical) associated with Baxdrostat

Literatures (Medical) associated with Baxdrostat

01 Jan 2027·CURRENT PROBLEMS IN CARDIOLOGY

Emerging therapeutics in hypertension: Evidence, clinical readiness, and implementation

Review

Author: Sharma, Kamal ; Kulkarni, Kedar ; Chowdhary, Rahul ; Ghay, Pooja ; Mehta, Shubh ; Ghay, Sahil ; Bhadania, Anshul ; Shivanne Gowda, Darshan ; Laffin, Luke ; Kaur, Baneet ; Tavethia, Jonsi ; Nanjundappa, Aravinda

Hypertension remains the leading modifiable contributor to cardiovascular disease worldwide, yet diagnosis, sustained treatment, and blood pressure (BP) control remain inadequate. This narrative review evaluates emerging therapeutics that are changing how hypertension is measured, phenotyped, treated, and organized. A targeted search of PubMed/MEDLINE, ClinicalTrials.gov, WHO reports, FDA, and major society guidelines was conducted through July 10, 2026. Therapeutic options were appraised according to evidence maturity, regulatory status, and clinical actionability. Validated ambulatory and home BP monitoring improves recognition of masked and white-coat hypertension, and home monitoring is recommended to guide medication titration. While cuffless BP measurement devices are on the rise, the 2025 multi-society guideline recommends against cuffless devices for diagnosis or management and recommends using them as adjunctive devices. Therapeutic innovation has advanced rapidly. The endothelin receptor antagonist aprocitentan and the aldosterone synthase inhibitor baxdrostat both lowered systolic BP in resistant hypertension and are now approved in the United States. Lorundrostat similarly reduced BP in phase 2 trials and is under FDA review. Angiotensinogen-directed RNA interference with zilebesiran produced durable BP lowering with infrequent dosing, although the effect was attenuated on background renin-angiotensin blockade, and the KARDIA-3 primary endpoint was not met. Gene transfer and genome editing remain preclinical, and multi-omics treatment selection is not yet established. No new agent or device has yet demonstrated a reduction in cardiovascular or kidney events, so the most credible near-term gains will come from integrating validated measurement, durable mechanism-directed therapy, and equitable implementation rather than any single therapy.

31 Dec 2026·BLOOD PRESSURE

Effect of fourth-line antihypertensive therapy on clinic systolic blood pressure in resistant hypertension: a systematic review and meta-analysis

Review

Author: Un Nisa, Noor ; Alam, Taha ; Jawed, Hira Arshad ; Rajdeep, Dhvanit ; Ibrahim, Taha ; Saad, Muhammad ; Jamshaid, Zainab ; Hussain, Muhammad ; Hassan, Muhammad ; Kamal, Sohaima ; Hotak, Rafiullah

INTRODUCTION/BACKGROUND:

Resistant hypertension (rHTN) is defined as uncontrolled blood pressure despite ≥3 antihypertensives, including a diuretic. While fourth-line-intensification is recommended, comparative evidence remains scattered.

RESEARCH QUESTIONS/HYPOTHESIS:

To evaluate the efficacy and safety of fourth-line antihypertensives in reducing clinic systolic blood pressure (SBP) in rHTN.

METHODS/APPROACH:

PubMed, Embase, Scopus, and Web of Science were searched (2015-2026) for randomized controlled trials (RCTs) with ≥4 weeks follow-up. Risk of bias was assessed using Cochrane RoB 2. A planned network meta-analysis was not performed because statistical inconsistency and transitivity violations rendered indirect comparisons unreliable. Therefore, pairwise meta-analyses were conducted using random-effects models, with results reported as mean differences (MD) or risk ratios (RR) with 95% confidence intervals (CIs).

RESULTS/DATA:

Eleven RCTs involving 3,931 adults with rHTN were included. Compared with placebo, the largest SBP reductions were observed with lorundrostat (MD -11.70 mmHg [95% CI -16.07, -7.33]) and baxdrostat 2 mg (MD -10.10 [-12.63, -7.58]). Baxdrostat 1 mg (MD -8.56 [-11.08, -6.04]) produced reductions similar to spironolactone (MD -7.95 [-10.10, -5.80]). Bisoprolol achieved a modest SBP reduction (MD -6.71 mmHg), whereas aprocitentan 12.5 mg reduced SBP by -3.80 mmHg [-6.65, -0.95]. No intervention significantly increased serious adverse events. Higher rates of any adverse events were observed with aprocitentan 25 mg (RR 1.89 [1.39, 2.57]) and doxazosin (RR 1.55 [1.09, 2.20]).

CONCLUSIONS:

Aldosterone-targeted therapies, including aldosterone-synthase inhibitors and spironolactone, provide clinically meaningful SBP reductions in rHTN without increasing serious adverse event risk. Future trials should clarify comparative efficacy and long-term outcomes.

01 Nov 2026·AMERICAN JOURNAL OF HYPERTENSION

Efficacy and safety of baxdrostat in the management of uncontrolled hypertension: a systematic review and meta-analysis

Review

Author: Wang, Jindong ; Liao, Yuan ; Zhao, Hui ; Xu, Tingli ; Gan, Pengcheng

Abstract:

Background:

Uncontrolled hypertension remains challenging. This meta-analysis evaluated baxdrostat, a selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension, focusing on dose-response for blood pressure (BP) reduction.

Methods:

We searched databases through March 2026 for randomized controlled trials (RCTs) comparing baxdrostat with placebo in patients with uncontrolled hypertension. Subgroup analysis used a 2 mg/day cutoff; continuous dose-response meta-analysis was performed for seated systolic BP.

Results:

Five RCTs were included. Compared with placebo, baxdrostat was associated with a greater reduction in seated systolic BP (mean difference: −6.25 mm Hg; 95% CI, −8.75 to −3.74), seated diastolic BP (mean difference: −2.92 mm Hg; 95% CI, −4.41 to −1.42), 24-hour ambulatory systolic BP (mean difference: −14.38 mm Hg; 95% CI, −17.21 to −11.54), and mean nocturnal systolic BP (mean difference: −13.19 mm Hg; 95% CI, −16.46 to −9.91). The BP control rate (defined as the proportion of patients achieving a post-treatment seated systolic BP < 130 mm Hg) was higher with baxdrostat (relative risk [RR]: 1.74; 95% CI, 1.23-2.46). Serum aldosterone was reduced (mean difference: −3.49 ng/dL; 95% CI, −4.30 to −2.69). Hyperkalemia risk was elevated (RR: 5.59; 95% CI, 3.47-9.02). Both low- (<2 mg) and high-dose (≥2 mg) baxdrostat lowered systolic/diastolic BP, but only high-dose improved BP control rate. Dose-response analysis showed a linear relationship: each 1 mg increase reduced seated systolic BP by 3.31 mm Hg.

Conclusion:

Baxdrostat is effective for uncontrolled hypertension with a linear dose-response effect, but led to an increased risk of hyperkalemia.

160

News (Medical) associated with Baxdrostat

30 Oct 2026

·www.biospace.com

AstraZeneca results: 9M and Q3 2026

Continued strong commercial performance and 12 positive Phase III programme readouts in the year to date CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca: Revenue and EPS summary 9M 2026 % Change Q3 2026 % Change $m Actual CER 1 $m Actual CER - Product Sales 43,962 7 5 15,066 5 5 - Alliance Revenue 2,806 33 32 1,107 36 36 Product Revenue 46,768 8 6 16,173 7 7 Collaboration Revenue 113 22 23 36 >3x >3x Total Revenue 46,881 8 7 16,209 7 7 Reported EPS ($) 5.62 10 11 2.02 23 26 Core 2 EPS ($) 8.00 14 14 2.79 17 19 Key performance elements for 9M 2026 (Growth numbers at constant exchange rates) Total Revenue up 7%, with double-digit growth in Oncology, R&I and Rare Disease offsetting headwinds from Farxiga and Brilinta loss of exclusivity and volume-based procurement in China Core Operating profit and Core EPS increased 14% 47 approvals in major regions since Q4 2025 results, including first approvals for four new medicines ( Etcamah , Baxfendy , Klygefa and Amlypave ) First Phase III data for three NMEs (tozorakimab, efzimfotase alfa and sonesitatug vedotin) Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “In the first nine months we saw strong commercial momentum with total revenue up 7% and Core EPS up 14%, driven by our diverse therapy areas and global presence. We have had approvals for four new medicines and reported 12 positive Phase III programme readouts with a collective peak year revenue potential well in excess of ten billion dollars. Our rich series of upcoming readouts in 2027 has a potential of more than twenty billion dollars. With multiple potential blockbuster assets in late-stage development and transformative technologies scaling rapidly, we are on track to deliver our 2030 ambition and to sustain growth through the next decade.” Guidance AstraZeneca reconfirms Total Revenue and Core EPS guidance 3 for FY 2026 at CER, based on the average foreign exchange rates through 2025. Total Revenue is expected to increase by a mid-to - high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% If foreign exchange rates for October 2026 to December 2026 were to remain at the average rates seen in September 2026, it is anticipated that Total Revenue in FY 2026 would benefit from a low single-digit percentage positive impact (unchanged) compared to the performance at CER, and Core EPS growth would be broadly similar (unchanged) to the growth at CER. Results highlights Table 1: Milestones achieved since the prior results announcement Phase III and other registrational data readouts Medicine Trial Indication Event Enhertu DESTINY-Lung04 1L HER2 m NSCLC Primary endpoint met Etcamah SERENA-4 1L HR+ HER2- advanced breast cancer Primary endpoint not met Imfinzi + tarlatamab DeLLphi-305 1L ES-SCLC (maintenance) Primary endpoint met Lynparza MONO-OLA1 1L BRCAwt ovarian cancer Dual primary endpoints met Tagrisso + Orpathys SAFFRON 2L+ EGFR m, MET-overexpressed and/or amplified NSCLC Primary endpoint met Tagrisso + Orpathys SANOVO 1L EGFR m, MET-overexpressed NSCLC Primary endpoint met volrustomig eVOLVE-Lung02 1L PD-L1 3x >3x 36 >3x >3x * See Tables 4 and 26 for further details of Collaboration Revenue Total Revenue 16,209 7 7 16,209 7 7 * See Tables 5 and 6 for Total Revenue by Therapy Area and by region Gross Margin (%) 82 - +1pp 82 - +1pp + Positive product mix effects − Pricing headwinds, including those driven by loss of exclusivity and VBP in China * Variations in Gross Margin can be expected between periods due to various factors, including fluctuations in foreign exchange rates, product seasonality and Collaboration Revenue R&D expense 3,894 6 7 3,645 3 3 * Core R&D: 22% of Total Revenue (23% for 9M 2026) + Increasing number of trials, and patients in those trials + Investments in transformative technologies + Addition of R&D projects from business development + Positive data readouts for high value pipeline opportunities that have ungated large late-stage trials * Variations in the year-on-year change in R&D expenses can be expected between periods due to the phasing of trial starts and completions SG&A expense 5,108 - - 3,909 2 2 * Core SG&A: 24% of Total Revenue (25% for 9M 2026) + Investment to support ongoing and future launches * Variations in the year-on-year change in SG&A expenses can be expected between periods due to the phasing of product launches and other programmes Other operating income and expense 4 277 >3x >3x 277 >2x >2x + Various partner milestones and royalties + Disposal of Zoryve interest Operating profit 4,387 22 26 5,855 17 20 + See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Operating Margin (%) 27 +3pp +4pp 36 +3pp +4pp Net finance expense 410 17 22 371 22 27 + Lower interest income on short-term deposits and higher interest expense on short-term borrowings + Higher discount unwind on lease liabilities, principally due to the new strategic R&D centre in Massachusetts, US − Reported Net finance expense benefitted from a lower discount unwind on contingent consideration liabilities Tax rate (%) 21 -1pp -1pp 21 - -1pp * Variations in the tax rate can be expected between periods EPS ($) 2.02 23 26 2.79 17 19 + See commentary above For dollar values in this table, the unit of change is percent. For Gross Margin, Operating Margin and Tax rate, the unit of change is percentage points (pp). In the table above, R&D expense, SG&A expense and Net finance expense are displayed as positive numbers. The plus and minus symbols next to comments denote the directional impact of the item being discussed. For example, a plus symbol next to a comment about an R&D item indicates that the item increased R&D expenditure relative to the prior year period. Corporate and business development Summit Therapeutics In October AstraZeneca completed a $2bn equity investment in Summit Therapeutics Inc. (Summit). The investment gives AstraZeneca rights equivalent to approximately 12.0% of Summit Therapeutics’ outstanding common stock, or approximately 10.6% on a fully diluted basis. AstraZeneca and Summit entered into a clinical collaboration agreement to evaluate sonesitatug vedotin in combination with Summit’s PD-1/VEGF bispecific antibody ivonescimab. The two companies also entered into a clinical collaboration with Daiichi Sankyo to evaluate Datroway in combination with ivonescimab. AstraZeneca and Summit intend to enter into an additional agreement initiating a global development programme combining other AstraZeneca cancer medicines, including additional ADCs, with ivonescimab. Kendall Square R&D Centre In October, AstraZeneca formally opened its new global strategic R&D centre, in Kendall Square, Cambridge, Massachusetts. The state-of-the-art facility builds on the Company’s existing presence in Boston and Cambridge, Massachusetts and will be home to nearly 2,000 world-class researchers and scientists. Reshaping for Sustainable Growth AstraZeneca is in a catalyst rich period with more than 180 pipeline projects driving its next wave of growth and scientific innovation. To capitalise on this opportunity, the Company has initiated the Reshaping for Sustainable Growth (RSG) programme to create additional capacity to invest behind its industry-leading pipeline and transformative technologies. Over the next three years, the programme will redeploy resources and strengthen capabilities across AstraZeneca’s existing business and therapy areas. The RSG programme is expected to cost up to $2.0bn in one-time restructuring costs and deliver $1.5bn in annualised pre-tax run-rate benefits. The savings generated will continue to be reinvested back into the Company, principally in the pipeline. The Company anticipates activities to be essentially complete by the end of 2029. insitro In October, AstraZeneca entered into a strategic drug discovery collaboration and licensing agreement with insitro. Using advanced AI systems, the collaboration will identify novel drug targets and advance the design of new therapeutics for MASH and cardiomyopathies. Under the terms of the agreement, insitro will receive an upfront payment of $40m, and is also eligible for up to approximately $1.46bn in potential development and commercial milestones, plus potential single digit royalties based on global commercial sales. AstraZeneca will have exclusive worldwide rights to advance selected programmes identified under the collaboration. Dizal Pharmaceutical Co In August, AstraZeneca completed the license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy , which is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. See Interim Financial Statements, Note 5, for further details. Sustainability highlights AstraZeneca ranked fifth on TIME Magazine’s 2026 World’s Best Companies list - its highest position to date and the top ranking among pharmaceutical companies - based on sustainability transparency, revenue growth, and employee satisfaction. Reporting calendar The Company intends to publish its FY and Q4 2026 results on 9 February 2027. Conference call A conference call and webcast for investors and analysts will begin today, 30 October 2026, at 14:30 UK time. Details can be accessed via astrazeneca.com . Notes Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2026 vs. 2025. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results. Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Tables 10 and 11 in the Financial Performance section of this document. The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the Cautionary statements section regarding forward-looking statements at the end of this announcement. Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, is recorded in Other operating income and expense in the Group’s financial statements. To read AstraZeneca's 9M & Q3 2026 Financial Results press release in full, read here . Contacts Global Media Relations team global-mediateam@astrazeneca.com +44 (0)1223 344 800

License out/inPhase 3Drug ApprovalClinical ResultFinancial Statement

30 Oct 2026

·www.astrazeneca.com

9M and Q3 2026 results

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Information for Suppliers Supplier Sustainability Hub Sustainable procurement A Catalyst Network For investor audiences and financial/business media only Continued strong commercial performance and 12 positive Phase III programme readouts in the year to date In the first nine months we saw strong commercial momentum with total revenue up 7% and Core EPS up 14%, driven by our diverse therapy areas and global presence. We have had approvals for four new medicines and reported 12 positive Phase III programme readouts with a collective peak year revenue potential well in excess of ten billion dollars. Our rich series of upcoming readouts in 2027 has a potential of more than twenty billion dollars. With multiple potential blockbuster assets in late-stage development and transformative technologies scaling rapidly, we are on track to deliver our 2030 ambition and to sustain growth through the next decade.” (Growth numbers at constant exchange rates (CER1)) Total Revenue up 7%, with double-digit growth in Oncology, R&I and Rare Disease offsetting headwinds from Farxiga and Brilinta loss of exclusivity and volume-based procurement in China Core Operating profit and Core2 Earnings Per Share (EPS) increased 14% 47 approvals in major regions since Q4 2025 results, including first approvals for four new medicines (Etcamah, Baxfendy, Klygefa and Amlypave) First Phase III data for three new molecular entities (NMEs) (tozorakimab, efzimfotase alfa and sonesitatug vedotin) Core Operating profit and Core2 Earnings Per Share (EPS) increased 14% 47 approvals in major regions since Q4 2025 results, including first approvals for four new medicines (Etcamah, Baxfendy, Klygefa and Amlypave) First Phase III data for three new molecular entities (NMEs) (tozorakimab, efzimfotase alfa and sonesitatug vedotin) 9M 2026 Total Revenue by Therapy Area. Growth at CER. 47% of revenue and the largest Therapy Area 36% of revenue. Respiratory & Immunology grew +10%, CVRM (−14%), Infectious Disease (-12%) 16% of revenue projects in our pipeline NMEs or major life-cycle management in Phase II or Phase III NMEs delivered against target of 20 by 2030 NMEs in our late-stage pipeline NMEs under review Matthew Bowden Company Secretary AstraZeneca PLC References 1. Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2026 vs. 2025. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results. 2. Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the amortisation of intangibles, impairments, legal settlements and restructuring charges. A full reconciliation between Reported EPS and Core EPS is provided in Tables 10 and 11 in the Financial Performance section of this document. 3. The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the Cautionary statements section regarding forward-looking statements at the end of this announcement. Corporate and financial

Phase 3Drug ApprovalClinical Result

13 Aug 2026

·www.fiercepharma.com

AZ's blood pressure newcomer Baxfendy fails to meet cost-effectiveness bar, ICER says

AstraZeneca’s newly approved, first-in-class hypertension drug Baxfendy does not clear the bar for effectiveness relative to its price, according to the Institute for Clinical and Economic Review (ICER), a U.S. non-profit drug price watchdog. In a draft report (PDF), ICER concludes Baxfendy is too expensive to meet traditional cost-effectiveness measures. For its assessment, ICER used a wholesale acquisition cost (WAC) of $900 for a supply of 30 Baxfendy tablets, adding up to an annual cost before discounts and rebates of $10,800. The WAC, or 'list price,' of a drug does not represent what patients ultimately pay at the pharmacy counter. ICER also used the same price as a placeholder to assess Mineralys Therapeutics’ investigational treatment lorundrostat, which carries the same mechanism of action as Baxfendy and is up for an FDA decision in December. ICER came to the same conclusion that Mineralys’ aldosterone synthase inhibitor (ASI) does not measure up. “At their current WAC-based price and placeholder price, the incremental cost-effectiveness ratios for baxdrostat and lorundrostat were well above commonly used cost-effectiveness thresholds,” ICER wrote. While acknowledging the limitations of cross-trial comparisons, ICER added that their analysis could not differentiate whether “one agent has superior blood pressure lowering over the other.” ICER wrote that the health benefits of baxdrostat or lorundrostat are “promising but inconclusive” compared to those for generic blood pressure medicines such as spironolactone, eplerenone and amiloride. Baxfendy was approved by the FDA in May of this year to be used with other antihypertensive therapies in patients with high blood pressure that can’t be adequately controlled. In its report, ICER also said that questions remain about the “long-term effects of ASIs,” and their efficacy and safety in subgroups, specifically those with chronic kidney disease. In response, an AZ spokesperson pointed out that millions of people in the U.S. do not have their blood pressure under control despite being on multiple medications. “Aldosterone synthase inhibitors, including Baxfendy, represent the first new innovation in hypertension management in more than two decades. Baxfendy offers patients clinically meaningful blood pressure reductions supported by a robust body of scientific evidence, and we are continuing to support access to this new therapy for patients across the U.S.," the spokesperson added. The approval of Baxfendy was backed by results from a phase 3 trial which showed that it helped curb blood pressure at statistically significant and clinically meaningful levels in patients who were already taking two or more hypertension meds. At week 12 of the study, a 2 mg dose of Baxfendy helped reduce patients’ blood pressure on average by nearly 10 mmHg when adjusted for placebo. The reduction in mean seated systolic blood pressure in the trial’s placebo cohort clocked in at 5.8 mmHg. AZ leadership has pegged the peak sales potential of Baxfendy at $5 billion, with the medication expected to play a role in the company achieving its goal to reach annual sales of $80 billion by 2030. AZ acquired Baxfendy in a $1.3 billion buyout of its developer CinCor Pharma in 2023.

AcquisitionPhase 3Drug ApprovalNDAClinical Result

100 Deals associated with Baxdrostat

External Link

KEGG	Wiki	ATC	Drug Bank
D12789	-	C02KN02	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	United States	AstraZeneca AB	15 May 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Resistant hypertension	NDA/BLA	United States	AstraZeneca PLC	02 Dec 2025
Hyperaldosteronism	Phase 3	United States	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	China	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Japan	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Australia	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Canada	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	France	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Germany	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	India	AstraZeneca PLC	07 Aug 2025
Hyperaldosteronism	Phase 3	Italy	AstraZeneca PLC	07 Aug 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06268873 (BaxDuo-Arctic, ASN2026)	Phase 3	Renal Failure, Progressive, With Hypertension	2,534	Baxdrostat 1 mg/Dapagliflozin 10 mg	jaajidwais(xkaiiriqzz) = ogwcgrpsvm swxmhvhxio (wusvgobsgj, 15.7) View more	Positive	23 Oct 2026
NCT06168409 (Bax24, CTgov)	Phase 3	Resistant hypertension	218	Placebo	sfjirclrsh(wseylhzuyc) = qjhmzcnhkf ifwxylyybv (jwlbfxaatm, chccvfjtxk - lclktfyimq) View more	-	06 Aug 2026
NCT06344104 (BaxAsia, ISN WCN2026)	Phase 3	Resistant hypertension	326	Baxdrostat 1 mg	hkaqplvgbk(kweqiyigkq) = Participants with rHTN were on 3 (67.9%), 4 (26.1%) or 5 (6.1%) antihypertensive medications at baseline. tnjvjjbscp (cfuwkfpzhc )	Positive	01 Apr 2026
NCT06034743 (WCN26-3663 BAXHTN, ISN WCN2026)	Phase 2	Resistant hypertension	794	Baxdrostat 1 mg	dmdjjacfji(igsrbianmz) = eqkzrlcrmh vrhyjjccax (pctvplsbqz, -11.5 to -5.8)	Positive	01 Apr 2026
				Baxdrostat 2 mg	dmdjjacfji(igsrbianmz) = hjkawxztqn vrhyjjccax (pctvplsbqz, -12.6 to -7.0)
NCT04605549 (SPARK, CTgov)	Phase 2	Hyperaldosteronism	15	CIN-107 (CIN-107)	jwtsinuwcc = cyztoewgzq ttumhrxuuf (eaducwqrlz, phzosdqohc - xnwrwkjqwc) View more	-	03 Mar 2026
				CIN-107 (CIN-107 2 mg Part 1 - Before Titration)	lsveuaehyx(awozgvaiss) = sdzknmuyvq jjzkdicrmz (wupeoqqrjw, fahnpgqshp - hnspfuqspp) View more
NCT06168409 (Bax24, Pubmed \| Lancet)	Phase 3	Resistant hypertension	217	Baxdrostat 2 mg	yxhvhlhyez(lkbaswnkyw) = ejfeksvqcy kiwtzovlas (jtbtnkrtpp ) View more	Positive	01 Mar 2026
				Placebo	yxhvhlhyez(lkbaswnkyw) = baglqzpxoe kiwtzovlas (jtbtnkrtpp )
NCT06336356 (CTgov)	Phase 2	Hypertension	48	Baxdrostat (Baxdrostat 2 mg)	ghtpuvtrxg = mldmbaddfm mbhsoanvbp (jqxpzeadav, ztgtlupblq - ahlyxsypdl) View more	-	17 Dec 2025
				placebo (Placebo)	ghtpuvtrxg = msyjomstuy mbhsoanvbp (jqxpzeadav, dyssctbyxh - edarywzqbi) View more
NCT06168409 (Bax24, Company_Website) Manual	Phase 3	Resistant hypertension	218	Baxdrostat 2mg	ebfuoppouv(zgguiqovje) = cpqmkmckjs msftrhvrli (ewcnzxsqes, -18.8 to -14.3) Met View more	Positive	09 Nov 2025
				placebo	ebfuoppouv(zgguiqovje) = wyrarydils msftrhvrli (ewcnzxsqes, -4.7 to -0.4) Met View more
NCT05432167 (FigHTN, ASN2025)	Phase 2	Hypertensive Nephropathy	-	Baxdrostat	ftdhfpmcxr(kacfypbrxe) = lyzxqairyi oqbwzhxsdb (qutyuqcisx ) View more	Positive	08 Nov 2025
				placebo	ftdhfpmcxr(kacfypbrxe) = rcsxowtgsu oqbwzhxsdb (qutyuqcisx ) View more
NCT06034743 (BaxHTN, Pubmed \| N Engl J Med)	Phase 3	Resistant hypertension	794	Baxdrostat 1 mg	xcquxpgmzu(wlrirohlqy) = bgxevshafn flhhrzlzqp (kokiaktdjo, -16.5 to -12.5) View more	Positive	09 Oct 2025
				Baxdrostat 2 mg	xcquxpgmzu(wlrirohlqy) = tcnwghqsgz flhhrzlzqp (kokiaktdjo, -17.6 to -13.7)

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