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FDA approval · AstraZeneca · Cardiology

Baxfendybaxdrostat

FDA approves the first aldosterone synthase inhibitor as add-on therapy for hypertension.

CompareAstraZeneca press release
FDA approval · New moleculeFirst in class45-second read

Baxfendybaxdrostat

AstraZeneca · Aldosterone synthase inhibitor · Cardiology

Bottom line for your patients

Adults whose blood pressure is not adequately controlled on other medicines have an add-on option that works by inhibiting aldosterone production. The pivotal trial enrolled patients already on two or more drugs. Potassium and sodium need to be checked before and during treatment.

Drug brief
Drug IQ
Who it is for
Adults with hypertension not adequately controlled on other agents, in combination with other antihypertensive drugs.
What changes
BaxHTN compared Baxfendy 2mg and 1mg with placebo, each given once daily on top of standard of care antihypertensive therapy that included a diuretic.
The evidence
At week 12, placebo-adjusted reduction in mean seated systolic blood pressure was 9.8 mmHg with the 2mg dose and 8.7 mmHg with the 1mg dose (both p<0.001). The reduction with placebo was 5.8 mmHg.Placebo-controlled randomized trialBaxHTN · Phase 3 · 796 participantsRandomized against placebo: shows that it works, not how it compares with existing treatments.
Watch for
Warnings for hyperkalemia and hyponatremia. Most frequently reported adverse reactions for the 1 mg and 2 mg doses were hyperkalemia (6.6%, 10.2%), hypotension (2.1%, 3.6%), hyponatremia (2.1%, 3.2%), dizziness (3.0%, 2.9%), and muscle spasms (1.8%, 2.9%).
How it is given
Oral2 mg orally once daily; 1 mg once daily for patients at increased risk of hyperkalemia or hyponatremia
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.

Clinical summary

Baxfendy is an oral aldosterone synthase inhibitor for adults whose hypertension is not adequately controlled on other agents, used in combination with other antihypertensive drugs. In the BaxHTN Phase III trial, the 2mg dose lowered mean seated systolic blood pressure by 15.7 mmHg from baseline at week 12, a placebo-adjusted reduction of 9.8 mmHg. It can cause hyperkalemia and hyponatremia, so serum potassium and sodium should be assessed before starting and monitored periodically.

From the source 13

AstraZeneca press release

The AstraZeneca press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. 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.

    Backs · First in class aldosterone synthase inhibitor; indication

  2. 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.

    Backs · 15.7 mmHg absolute and 9.8 mmHg placebo-adjusted reduction at week 12 with 2mg; p<0.001

  3. 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).

    Backs · 8.7 mmHg placebo-adjusted reduction with 1mg

View all 13 lines

  1. The reduction in mean seated SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8).

    Backs · 5.8 mmHg reduction with placebo

  2. A total of 796 patients were characterized 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].

    Backs · 796 patients; once daily; on top of standard of care with a diuretic

  3. 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.

    Backs · Phase 3; patients on two or more medications

  4. The primary endpoint was assessed during a 12-week double-blind, placebo-controlled period.

    Backs · 12-week double-blind, placebo-controlled primary period

  5. The recommended dosage of BAXFENDY is 2 mg orally once daily. For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg orally once daily.

    Backs · Dosing 2 mg once daily, 1 mg for those at risk

  6. BAXFENDY is an aldosterone synthase inhibitor indicated, in combination with other antihypertensive drugs, for the treatment of hypertension to lower blood pressure in adults who are not adequately controlled on other agents.

    Backs · Approved population

  7. BAXFENDY can cause hyperkalemia. Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment.

    Backs · Hyperkalemia warning and potassium monitoring

  8. BAXFENDY can cause hyponatremia.

    Backs · Hyponatremia warning

  9. Most frequently reported adverse reactions (≥2% with BAXFENDY and greater (≥1%) than placebo in pooled, placebo-controlled trials) reported for BAXFENDY 1 mg and 2 mg, respectively, were hyperkalemia (6.6%, 10.2%), hypotension (2.1%, 3.6%), hyponatremia (2.1%, 3.2%), dizziness (3.0%, 2.9%), and muscle spasms (1.8%, 2.9%).

    Backs · Adverse reaction rates 6.6%, 10.2%, 2.1%, 3.6%, 3.2%, 3.0%, 2.9%, 1.8%

  10. Baxfendy | baxdrostat | 5/15/2026 | To treat hypertension in combination with other antihypertensive drugs

    Backs · FDA action date 2026-05-15 (from FDA Novel Drug Approvals for 2026 table, https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026; the AstraZeneca release is dated 18 May 2026 and does not state the action date)

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