REG - AstraZeneca PLC - Baxfendy approved in the US for hypertension

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RNS Number : 6126E  AstraZeneca PLC  18 May 2026

18 May 2026

Baxfendy approved in the US as the first and only aldosterone synthase
inhibitor treatment for adults with hypertension

Approval based on BaxHTN Phase III results showing statistically significant
and clinically meaningful reduction in systolic blood pressure in patients
with uncontrolled or resistant hypertension

Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg
placebo-adjusted) from baseline in BaxHTN trial

AstraZeneca's Baxfendy (baxdrostat) has been approved in the US as a
first-in-class aldosterone synthase inhibitor (ASI) for the treatment of
hypertension in combination with other antihypertensive medications, to lower
blood pressure in adults who are not adequately controlled.

 

There are 1.4 billion people worldwide living with hypertension.(1) In the US,
approximately 50% of patients living with hypertension who are already taking
multiple antihypertensive medications still struggle with persistently
elevated blood pressure,(2) which is a leading risk factor for cardiovascular
disease and premature death.(3,4) Hypertension is the most prevalent and
significant modifiable cardiovascular risk factor worldwide, accounting for
more deaths and disability than any other modifiable risk.(5-7)

 

Baxfendy is a first-in-class, highly selective and potent ASI designed to
lower blood pressure in a new way by specifically inhibiting the production of
aldosterone,(8) a hormone that raises blood pressure to unhealthy levels and
increases the risk of heart and kidney problems.(9-11)

 

The approval by the US Food and Drug Administration (FDA) was based on
positive results from the BaxHTN Phase III trial,(12) with Baxfendy
demonstrating statistically significant and clinically meaningful seated
systolic blood pressure reduction at both 2mg and 1mg doses in patients with
uncontrolled and resistant hypertension on two or more medications. Baxfendy
was generally well-tolerated with no unanticipated safety findings.

( )

Dr. Bryan Williams, Chair of Medicine at University College London, and BaxHTN
primary investigator, said: "We have been waiting for an innovative medication
like Baxfendy for hypertension for many years. Its novel way of lowering blood
pressure has the potential to transform clinical practice by targeting a root
cause of persistently uncontrolled hypertension. In addition, the nearly
double-digit placebo-adjusted systolic blood pressure reduction achieved with
Baxfendy is exciting and clinically meaningful for clinicians and patients.
Epidemiological data indicate that a 10 mmHg decrease in systolic blood
pressure is associated with a roughly 20% lower risk of serious cardiovascular
events."

 

John M. Clymer, Executive Director, National Forum for Heart Disease &
Stroke Prevention, said: "Hypertension remains a staggeringly widespread
silent killer and a leading risk factor for stroke, heart attack, kidney
damage and dementia. Tens of millions of people struggle to control their
blood pressure despite lifestyle changes and currently available treatments.
Innovative, new treatments could help millions protect their heart, kidney and
brain health."

 

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit,
AstraZeneca, said: "The approval of Baxfendy offers a much‑needed,
first-in-class innovation for people living with persistently uncontrolled
hypertension who have not responded to or tolerated existing medicines. In the
US, about 23 million patients are uncontrolled despite being on two or more
medicines for hypertension, which is a disease that has seen little
therapeutic progress for the past two decades."

 

In the BaxHTN Phase III trial,(13) published in the New England Journal of
Medicine
(https://www.nejm.org/stoken/default+domain/REPRINTS_37030/full?redirectUri=/doi/full/10.1056/NEJMoa2507109)
,(12) Baxfendy (baxdrostat) demonstrated statistically significant and
clinically meaningful efficacy for the treatment of patients with hypertension
on top of standard of care. At week 12, the absolute reduction from baseline
in mean seated SBP was 15.7 mmHg (95% confidence interval  CI , -17.6 to
-13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0;
p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from
baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction
was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated
SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent
across both uncontrolled and treatment-resistant subgroups.

 

Notes

 

Uncontrolled hypertension

Hypertension is a medical condition characterised by consistently high blood
pressure levels, affecting an estimated 1.4 billion people worldwide.(1,14,15)
Over time, this can damage blood vessels and vital organs, increasing the risk
of serious health problems such as heart attack, stroke, heart failure and
kidney disease.(14,15)

Treated but uncontrolled patients with hypertension are at a significantly
greater risk of all-cause mortality, heart-disease specific mortality,
stroke-related mortality, CVD-specific mortality and dementia than patients
whose hypertension is controlled. A large meta-analysis found that lowering
systolic blood pressure by 10 mmHg can reduce the risk of major adverse
cardiovascular events by around 20%,(16) underscoring the urgent need for new
treatments that target a key hypertension pathway at its source.

An observational study of nearly 60,000 patients studied over a median of 9.7
years showed that a 9.5 mmHg increase in SBP was associated with a 30%
increase in risk of all-cause mortality and 41% increase in risk of
cardiovascular death.(17) Studies have shown that increased night-time blood
pressure is associated with higher cardiovascular risk,(18,19) and patients
with hypertension have a higher risk of cardiovascular events like heart
attack, stroke and death around the time of their morning blood pressure
surge.(20,21)

 

Aldosterone, a hormone that raises blood pressure to unhealthy levels by
promoting sodium and water retention(9,10) is a key contributor to
persistently uncontrolled hypertension. Elevated aldosterone levels, along
with factors such as obesity, high salt intake and various genetic or
secondary conditions,(22) are strongly associated with poor blood pressure
control and the progression of heart failure and kidney disease. When left
untreated, hypertension significantly increases the risk of cardiovascular and
kidney-related complications.(5,14,23)

 

BaxHTN trial

The BaxHTN Phase III trial(13) had three components to it that supported the
following endpoints. The primary endpoint was assessed during a 12-week
double-blind, placebo-controlled period. A total of 796 patients were
characterised in a 1:1:1 ratio to receive Baxfendy 2mg, 1mg or placebo once
daily on top of standard of care [2 antihypertensive agents at baseline, one
of which is a diuretic for uncontrolled hypertension and ≥ 3
antihypertensive agents at baseline, one of which is a diuretic for resistant
hypertension].The primary efficacy endpoint was the difference in mean change
from baseline in seated SBP at week 12 between participants treated with
baxdrostat (2mg or 1mg separately) and participants treated with placebo.
Persistence of efficacy was assessed during a randomised withdrawal period
from week 24 to week 32. Approximately 300 patients treated with Baxfendy 2mg
were re-randomised in a 2:1 ratio to either continue receiving baxdrostat 2mg
or placebo for the 8 weeks. SBP at the end of the 8 weeks was compared with
placebo and the Baxfendy 2mg dose. Long-term safety was assessed at the end of
the 52 weeks compared to a standard of care arm.

 

Additional confirmatory secondary endpoints include the effect of Baxfendy
versus placebo on seated SBP at week 12 in the resistant hypertension
subpopulation, the effect of Baxfendy versus placebo on seated diastolic blood
pressure at week 12, and proportion of participants achieving seated SBP less
than 130 mmHg at week 12.

 

Baxfendy and the clinical development programme

Baxfendy is a first-in-class, highly selective and potent, oral, small
molecule that inhibits aldosterone synthase,(8) an enzyme encoded by the
CYP11B2 gene, which is responsible for the synthesis of aldosterone in the
adrenal gland.(10) In clinical trials, Baxfendy was observed to significantly
lower aldosterone levels without affecting cortisol levels across a wide range
of doses.(24,25)

 

As part of a broad development programme, Baxfendy is currently being
investigated in clinical trials in other conditions where high aldosterone
plays a role in elevating cardiorenal risk, including as a monotherapy for
primary aldosteronism,(26) and in combination with dapagliflozin for chronic
kidney disease and hypertension,(27,28) and the prevention of heart failure in
patients with hypertension.(29) Additional clinical data for Baxfendy in
hypertension includes positive data from the Bax24 Phase III trial,(30) which
showed a statistically significant and highly clinically meaningful
placebo-adjusted reduction of 24-hour ambulatory systolic blood pressure in
patients with resistant hypertension, with full results published in The
Lancet
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02549-8/fulltext)
.(31)

 

AstraZeneca acquired Baxfendy through its purchase of CinCor Pharma, Inc. in
February 2023.(32)

 

AstraZeneca in CVRM
(https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html)

Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms
one of AstraZeneca's main disease areas and is a key growth driver for the
Company. By following the science to understand more clearly the underlying
links between the heart, kidneys, liver and pancreas, AstraZeneca is investing
in a portfolio of medicines for organ protection by slowing or stopping
disease progression, and ultimately paving the way towards regenerative
therapies. The Company's ambition is to improve and save the lives of millions
of people, by better understanding the interconnections between CVRM diseases
and targeting the mechanisms that drive them, so we can detect, diagnose and
treat people earlier and more effectively.

 

AstraZeneca (https://www.astrazeneca.com/)

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com and follow the Company on Social Media
@AstraZeneca.

Contacts

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.

 

References

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Cardiovascular Disease Events Risk in Treatment-Resistant
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23.  Jones DW, et al. 2025
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32.  AstraZeneca 2023. Acquisition of CinCor Pharma complete. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html.
Accessed April 2026.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

 

 

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