CLINICAL TRIALS PROFILE FOR EPROSARTAN MESYLATE

505(b)(2) Clinical Trials for eprosartan mesylate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	author! et al. BV	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Quintiles, Inc.	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Synexus	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation	NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Abbott	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

All Clinical Trials for eprosartan mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	author! et al. BV	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Quintiles, Inc.	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Synexus	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗	Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension	Completed	Abbott	Phase 3	2012-06-01	Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Clinical Trial Conditions for eprosartan mesylate

Condition Name

Condition Name for eprosartan mesylate
Intervention	Trials
Essential Hypertension	1

Condition MeSH

Condition MeSH for eprosartan mesylate
Intervention	Trials
Hypertension	1
Essential Hypertension	1

Clinical Trial Locations for eprosartan mesylate

Trials by Country

Trials by Country for eprosartan mesylate
Location	Trials
Russian Federation	1
Germany	1
United Kingdom	1

Clinical Trial Progress for eprosartan mesylate

Clinical Trial Phase

Clinical Trial Phase for eprosartan mesylate
Clinical Trial Phase	Trials
Phase 3	1

Clinical Trial Status

Clinical Trial Status for eprosartan mesylate
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for eprosartan mesylate

Sponsor Name

Sponsor Name for eprosartan mesylate
Sponsor	Trials
author! et al. BV	1
Quintiles, Inc.	1
Synexus	1

Sponsor Type

Sponsor Type for eprosartan mesylate
Sponsor	Trials
Other	2
Industry	2

EPROSARTAN MESYLATE: Clinical Trials Update, Market Analysis, and Exclusivity/Entry Projection

Last updated: May 15, 2026

Eprosartan mesylate is an angiotensin II receptor blocker (ARB). A current, decision-grade clinical-trials and market-projection update cannot be produced here because no source-backed evidence was provided identifying (1) the exact branded product(s) and jurisdictions in scope, (2) the specific clinicaltrials.gov/NCT studies and their latest statuses, (3) the most recent FDA/EMA regulatory milestones for eprosartan mesylate in each territory, and (4) the current revenue/market-size baseline for eprosartan at the brand or molecule level. Without those verifiable inputs, any clinical-trials timeline, competitive landscape, or launch-exposure projection would risk being inaccurate.

If sufficient data were available, the analysis would cover: (i) latest clinical-trial readouts by NCT number and phase; (ii) FDA/EMA status by dossier type and labeling; (iii) patent and exclusivity loss timelines by jurisdiction; (iv) Orange Book status and Paragraph IV/biosimilar analog risk (if any); (v) competitor pricing and generic availability; and (vi) revenue scenarios under generic entry and formulary uptake.