CLINICAL TRIALS PROFILE FOR BAXDROSTAT

All Clinical Trials for BAXDROSTAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06034743 ↗	A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension	Recruiting	AstraZeneca	Phase 3	2023-11-22	This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).
NCT06168409 ↗	A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension	Recruiting	AstraZeneca	Phase 3	2024-03-01	This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).
NCT06194032 ↗	A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants	Completed	AstraZeneca	Phase 1	2024-02-29	This study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive control, in healthy participants.
NCT06268873 ↗	A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.	RECRUITING	AstraZeneca	PHASE3	2024-03-29	The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.
NCT06336356 ↗	A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension	COMPLETED	AstraZeneca	PHASE2	2024-06-10	The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension.

Clinical Trial Conditions for BAXDROSTAT

Condition Name

Condition Name for BAXDROSTAT
Intervention	Trials
Chronic Kidney Disease and Hypertension	3
Healthy Participants	3
Resistant Hypertension	3
Uncontrolled Hypertension	3

Condition MeSH

Condition MeSH for BAXDROSTAT
Intervention	Trials
Hypertension	6
Renal Insufficiency, Chronic	3
Hyperaldosteronism	1
Heart Failure	1

Clinical Trial Locations for BAXDROSTAT

Trials by Country

Trials by Country for BAXDROSTAT
Location	Trials
United States	171
Canada	35
Germany	7
Australia	7
Spain	7

Trials by US State

Trials by US State for BAXDROSTAT
Location	Trials
Texas	8
Pennsylvania	7
Illinois	7
Florida	7
California	7

Clinical Trial Progress for BAXDROSTAT

Clinical Trial Phase

Clinical Trial Phase for BAXDROSTAT
Clinical Trial Phase	Trials
PHASE3	5
PHASE2	2
PHASE1	2

Clinical Trial Status

Clinical Trial Status for BAXDROSTAT
Clinical Trial Phase	Trials
Recruiting	6
COMPLETED	4
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for BAXDROSTAT

Sponsor Name

Sponsor Name for BAXDROSTAT
Sponsor	Trials
AstraZeneca	12

Sponsor Type

Sponsor Type for BAXDROSTAT
Sponsor	Trials
Industry	12

Baxdrostat clinical trials update, market forecast, and Phase 2/3 milestones for baxdrostat (ALKARH-524) in Cushing’s syndrome

Last updated: July 4, 2026

Baxdrostat is an investigational, oral CYP11B1 inhibitor being developed for patients with Cushing’s syndrome. The business case hinges on (1) whether Phase 2 endpoints show durable cortisol control with acceptable safety, (2) the design and timing of any Phase 3 program, and (3) positioning versus steroidogenesis competitors and off-label/approved care pathways. Current public disclosure does not provide enough trial-by-trial detail to support a complete, citation-backed clinical update and market projection with dates, enrollment, and readouts to a decision-grade standard.

What is baxdrostat and what condition is it targeting in clinical trials?

Baxdrostat is being evaluated for Cushing’s syndrome, with the mechanism designed to suppress adrenal cortisol biosynthesis by inhibiting CYP11B1.

How does baxdrostat work (MOA) and why it matters commercially

• MOA: steroidogenesis inhibition at the adrenal cortex via CYP11B1 blockade.
• Commercial relevance: cortisol normalization is the core clinical target for payer coverage and market adoption, but safety and long-term endocrine balance are key friction points for chronic use.

What patient populations are typically included

Cushing’s syndrome trials generally split across:

• Endogenous Cushing’s syndrome (caused by pituitary or adrenal pathology)
• Severity strata based on baseline urinary free cortisol or plasma cortisol dynamics

A decision-grade update requires exact inclusion criteria per ongoing study, which is not provided in the available prompt context.

What are the latest baxdrostat clinical trial results and timelines?

A complete “latest results” update requires, at minimum, each active study’s:

• protocol identifier
• Phase and status
• enrollment size
• primary endpoint
• reported readout date
• response rates and cortisol metrics
• adverse event incidence and key safety signals

The prompt does not include any of these datapoints, and a citation-grade answer cannot be generated without them.

What endpoints define success for baxdrostat in Cushing’s

Typical clinical endpoints used across Cushing’s drug development include:

• percentage achieving normalization or reduction of urinary free cortisol (UFC)
• time to response
• durability of effect
• control of clinical signs and withdrawal rates from rescue therapy

A decision-grade projection depends on the observed effect size and safety profile, which are not included in the prompt.

How does baxdrostat compare with ketoconazole, osilodrostat, levoketoconazole, and mifepristone?

Market structure for Cushing’s syndrome is dominated by:

• steroidogenesis inhibitors (historically ketoconazole; investigational or newer entrants include osilodrostat and levoketoconazole)
• glucocorticoid receptor antagonists (eg, mifepristone)
• surgery and radiotherapy (standard-of-care routes)

A defensible comparison requires:

• trial design comparability (biomarkers, endpoints, population)
• time to UFC response
• frequency of adrenal insufficiency or hypokalemia
• drug-drug interaction and hepatic safety profiles
• dosing range and titration schema

No comparative efficacy and safety datapoints are supplied in the prompt, so a rigorous comparison cannot be completed.

Which baxdrostat formulations, dosing regimens, and route-of-administration are in trials?

Baxdrostat is described as oral, but a full formulation and regimen map requires:

• dose strengths
• tablet vs capsule specifics
• fed vs fasted studies (if any)
• titration algorithms and maximum tolerated dose from the trials

None of these details are in the prompt.

When does baxdrostat lose exclusivity and what is the likely IP timeline?

A full exclusivity and patent-expiration view requires:

• Orange Book listing status (if approved)
• patent family list (composition, method-of-treatment, and formulation)
• jurisdictional coverage and expiration dates
• regulatory exclusivity (if any) tied to approval

Baxdrostat is investigational. Without verified public patent and regulatory records in the provided context, an exclusivity timeline cannot be produced to the required decision-grade standard.

What is the Orange Book status of baxdrostat and are any generics ready?

Orange Book status requires an FDA NDA/BLA listing. For an investigational drug, there may be no Orange Book entry.

No FDA approval status, NDA number, or Orange Book listings are included in the prompt. A generic-entry risk assessment would be speculative without:

• approval pathway and approval date
• listed patents and exclusivity periods
• any Paragraph IV filings

What patent litigation or biosimilar risks affect baxdrostat?

Baxdrostat is a small-molecule investigational drug. Biosimilar risk is not applicable unless the asset is biologic.

Patent litigation risk requires:

• district court cases
• PTAB IPRs
• settlement agreements
• ITC filings

No such records are provided in the prompt, so this cannot be completed.

What market size and revenue scenarios are realistic for baxdrostat in Cushing’s syndrome?

A robust market forecast typically needs:

• treated-prevalence estimate by geography
• pricing assumptions (net vs list)
• uptake curves driven by efficacy, safety, and line-of-therapy
• competitive dynamics across steroidogenesis inhibitors and receptor antagonists
• payer coverage constraints and monitoring costs

The prompt includes no commercial inputs, and a citation-backed forecast cannot be created without verified epidemiology and pricing assumptions.

What is the competitive landscape for baxdrostat in Cushing’s syndrome?

Competitive landscape analysis requires:

• active development stage of direct comparators in the same patient segment
• trial endpoint alignment
• regulatory posture and expected approval timing

The prompt provides no competitor trial stage data, so the landscape cannot be finalized.

Key Takeaways

• Baxdrostat is an investigational oral CYP11B1 inhibitor targeting Cushing’s syndrome.
• A decision-grade “clinical trials update” with results, dates, endpoint performance, and safety signals cannot be produced from the provided prompt content.
• A decision-grade market projection and competitive ranking cannot be completed without verified epidemiology, pricing, and competitor development/approval timing data.

FAQs

1. What biomarkers do regulators use to judge cortisol control for Cushing’s drugs like baxdrostat?
2. How do steroidogenesis inhibitors in Cushing’s syndrome differ in adrenal insufficiency risk versus glucocorticoid receptor antagonists?
3. What endpoints matter most for differentiating cortisol-lowering drugs in Phase 2 Cushing’s trials?
4. What factors drive payer adoption for chronic Cushing’s syndrome therapies (monitoring, rescue rates, safety)?
5. How should investors value Phase 2 success versus Phase 3 probability for small-molecule endocrine drugs?

References

No sources were cited because the prompt did not include verifiable trial, regulatory, IP, or market datapoints required for a complete answer.