CLINICAL TRIALS PROFILE FOR ATRASENTAN HYDROCHLORIDE

All Clinical Trials for ATRASENTAN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00017264 ↗	Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2002-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma.
NCT00036543 ↗	A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer	Completed	Abbott	Phase 3	2001-05-01	This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.
NCT00036556 ↗	Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer	Completed	Abbott	Phase 3	2001-06-01	This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
NCT00038662 ↗	Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure	Completed	Abbott	Phase 2	2002-05-01	The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).
NCT00039429 ↗	Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2003-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
NCT00039429 ↗	Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	2003-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
NCT00046943 ↗	Atrasentan in Treating Patients With Prostate Cancer	Completed	Abbott	Phase 3	2002-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.

Clinical Trial Conditions for ATRASENTAN HYDROCHLORIDE

Condition Name

Condition Name for ATRASENTAN HYDROCHLORIDE
Intervention	Trials
Prostate Cancer	5
Diabetic Nephropathy	5
Chronic Kidney Disease	4
IgA Nephropathy	3

Condition MeSH

Condition MeSH for ATRASENTAN HYDROCHLORIDE
Intervention	Trials
Kidney Diseases	9
Prostatic Neoplasms	7
Diabetic Nephropathies	6
Renal Insufficiency, Chronic	4

Clinical Trial Locations for ATRASENTAN HYDROCHLORIDE

Trials by Country

Trials by Country for ATRASENTAN HYDROCHLORIDE
Location	Trials
United States	303
Canada	29
United Kingdom	20
Australia	16
France	8

Trials by US State

Trials by US State for ATRASENTAN HYDROCHLORIDE
Location	Trials
California	13
Pennsylvania	13
North Carolina	11
Georgia	11
Florida	11

Clinical Trial Progress for ATRASENTAN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ATRASENTAN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 3	7
Phase 2/Phase 3	1
Phase 2	11

Clinical Trial Status

Clinical Trial Status for ATRASENTAN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	15
Recruiting	2
Terminated	2

Clinical Trial Sponsors for ATRASENTAN HYDROCHLORIDE

Sponsor Name

Sponsor Name for ATRASENTAN HYDROCHLORIDE
Sponsor	Trials
Abbott	6
AbbVie (prior sponsor, Abbott)	4
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for ATRASENTAN HYDROCHLORIDE
Sponsor	Trials
Industry	15
Other	7
NIH	5

ATRASENTAN HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 9, 2026

What Is the Current Status of Atrasentan Hydrochloride in Clinical Trials?

Atrasentan hydrochloride is an investigational drug primarily developed for the treatment of kidney diseases, especially diabetic kidney disease and nephropathy. As of 2023, clinical development focused on evaluating its efficacy in reducing proteinuria and slowing disease progression.

Phase and Enrollment

• Phase 3 trials: In progress, targeting endpoints such as decline in glomerular filtration rate (GFR) and reduction of proteinuria.
• Status: As of 2023, no definitive completion or submission for regulatory approval has been announced publicly.
• Sample sizes: Typically involve 500–1000 patients, with ongoing recruitment and data collection.

Clinical Trial Framework

Trial Name	Phase	Population	Primary Endpoint	Status (2023)
SONAR	3	Patients with diabetic nephropathy	Composite of RRT initiation or doubling of serum creatinine	Ongoing
Other Trials	2-3	Patients with proteinuria	Reduction in proteinuria	Active, recruiting

Key Challenges

• Demonstrating a significant clinical benefit over existing therapies.
• Managing potential safety concerns, including fluid retention and anemia.

How Does Atrasentan Hydrochloride Fit Into the Market Landscape?

Market Overview

The market for kidney disease drugs, particularly diabetic nephropathy treatments, is expanding. The global nephrology drug market was valued at approximately $5.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030.

Competitive Landscape

Drug	Mechanism	Approval Status	Market Share (Estimate)	Key Competitors
SGLT2 inhibitors (empagliflozin, canagliflozin)	Glucose reabsorption inhibition	Approved	45%	-
Endothelin receptor antagonists (e.g., atrasentan)	Block endothelin pathways	Investigational	0%	Bosentan, sitaxentan (withdrawn)

Differentiators and Market Need

• Atrasentan offers a targeted approach to reduce proteinuria by blocking endothelin-A receptors.
• It aims to fill therapeutic gaps where SGLT2 inhibitors have limited efficacy or contraindications.

Regulatory Environment

• The U.S. FDA and EMA policies encourage novel kinase or receptor targeting drugs for chronic kidney disease (CKD).
• The success of empagliflozin and canagliflozin accelerates approval pathways for similar agents.

What Are the Market Projections for Atrasentan Hydrochloride?

Sales and Revenue Forecasts

• 2024-2026: Limited sales unless Phase 3 results demonstrate significant efficacy and safety improvements.
• Post-approval: Potential revenues could reach $500 million annually within five years if approved and adopted broadly.

Adoption Drivers

• High prevalence of diabetic nephropathy, affecting over 40% of type 2 diabetes patients.
• Rising awareness and guidelines supporting endothelin receptor antagonists for kidney disease.
• Expanding use in combination therapies with existing standards.

Risks Impacting Market Penetration

• Clinical trial failures or safety concerns.
• Competition from new emerging therapies.
• Regulatory delays or unfavorable reimbursement policies.

What Are the Key Takeaways?

• Atrasentan hydrochloride remains in late-stage clinical trials with no FDA or EMA approval yet.
• The kidney disease drug market is expanding, driven by SGLT2 inhibitors; atrasentan aims to carve a niche for endothelin pathway inhibition.
• Successful commercialization depends on positive Phase 3 outcomes, safety profile, and market adoption.
• Industry investment consideration should weigh ongoing trial risks against significant unmet needs in diabetic kidney disease.

What Are the Top FAQs?

1. When could atrasentan hydrochloride be approved?
Approval hinges on positive Phase 3 results, which are expected around 2024–2025. Regulatory review might take an additional 12–18 months.

2. How does atrasentan compare to existing treatments?
It offers a different mechanism—endothelin receptor blockade—potentially providing additive benefits in reducing proteinuria, especially where SGLT2 inhibitors are insufficient.

3. What safety concerns are associated with atrasentan?
Fluid retention, edema, anemia, and hypotension are primary risks observed in earlier trials. Managing these risks is critical for regulatory approval.

4. What is the market size for atrasentan?
With diabetic nephropathy affecting millions worldwide, market potential could reach hundreds of millions of dollars annually post-approval, contingent on clinical success.

5. Which competitors pose the greatest threat?
Existing SGLT2 inhibitors dominate the market. If atrasentan demonstrates superior efficacy or safety, it can gain share; otherwise, it faces stiff competition.

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Sources:

[1] ClinicalTrials.gov. Atrasentan Trials.
[2] GlobalData. Nephrology Drug Market Report 2023.
[3] IQVIA. 2022 Market Insights.
[4] FDA and EMA regulation guidelines for CKD therapies.