CLINICAL TRIALS PROFILE FOR UNIVASC

All Clinical Trials for UNIVASC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00992862 ↗	A Relative Bioavailability Study of Moexipril HCl 15 mg Tablets Under Fasting Conditions	Completed	Paddock Laboratories, Inc.	Phase 1	1969-12-31	The purpose of this study is to compare the relative bioavailability of Moexipril HCl 15mg tablets (by Paddock Laboratories, Inc.) with that of Univasc® 15mg tablets (by Schwarz Pharma) following a single oral dose (1 x 15mg tablet) in healthy, adult subjects under fasting conditions.
NCT01669434 ↗	Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery	Completed	University of Nebraska	Phase 4	2015-06-01	Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Clinical Trial Conditions for UNIVASC

Condition Name

Condition Name for UNIVASC
Intervention	Trials
Healthy	1
Hypertension	1
Hypotension on Induction	1

Condition MeSH

Condition MeSH for UNIVASC
Intervention	Trials
Hypotension	1

Clinical Trial Locations for UNIVASC

Trials by Country

Trials by Country for UNIVASC
Location	Trials
United States	2

Trials by US State

Trials by US State for UNIVASC
Location	Trials
Nebraska	1
Pennsylvania	1

Clinical Trial Progress for UNIVASC

Clinical Trial Phase

Clinical Trial Phase for UNIVASC
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for UNIVASC
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for UNIVASC

Sponsor Name

Sponsor Name for UNIVASC
Sponsor	Trials
Paddock Laboratories, Inc.	1
University of Nebraska	1

Sponsor Type

Sponsor Type for UNIVASC
Sponsor	Trials
Other	1
Industry	1

UNIVASC Market Analysis and Financial Projection

Last updated: February 8, 2026

What is Univasc and its current clinical trial status?

Univasc, the brand name for quinapril, is an angiotensin-converting enzyme (ACE) inhibitor approved for treating hypertension and heart failure. Its development and approval date back to 1991 under Abbott Laboratories (now AbbVie).

As of 2023, Univasc is marketed primarily in the United States and select international markets. It does not have ongoing advanced clinical trials publicly listed for new indications; most research focused on its established uses. However, the broader class of ACE inhibitors continues to undergo clinical research for indications such as diabetic nephropathy and COVID-19-related complications.

How is the market landscape for ACE inhibitors, including Univasc?

The global ACE inhibitors market was valued at approximately USD 7.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2030, driven by an aging population and rising prevalence of hypertension and cardiovascular diseases [1].

Key market participants include:

• Merck & Co. (Ramipril)
• Novartis (Lisinopril)
• AstraZeneca (Perindopril)
• Boehringer Ingelheim (Captopril)
• AbbVie (Univasc)

Univasc holds a smaller market share compared to leaders like Lisinopril and Ramipril due to limited marketing presence outside North America.

What are the competitive advantages and challenges for Univasc?

Advantages:

• Similar efficacy profile to other ACE inhibitors.
• Once-daily dosing provides convenience.

Challenges:

• Patent expiration in many markets reduces exclusivity.
• Competitive landscape with multiple generic options.
• Limited pipeline for new indications or reformulations.
• Safety profiles similar to other ACE inhibitors limit differentiation.

How does Univasc compare to competitors in terms of market penetration?

Univasc's market share remains below 5% globally. Lisinopril dominates with around 40-50% share. Ramipril accounts for approximately 20%. Univasc's limited promotion and lack of new indications constrict its growth.

In the U.S., Univasc is listed in the FDA database but ranks behind generic Lisinopril and Ramipril in prescription volume. International markets see smaller presence, mainly where AbbVie maintains distribution channels.

What is the projected market outlook for Univasc?

The ACE inhibitors market is expected to grow moderate to 3.5% CAGR until 2030. Growth will depend on:

• Broader acceptance of ACE inhibitors in emerging markets.
• Competition from angiotensin receptor blockers (ARBs) and newer classes like SGLT2 inhibitors.
• Patent expiries influencing generic substitution rates.

Univasc’s sales will likely follow market trends, with limited upside unless new formulations or indications emerge or the drug is repositioned.

What regulatory and patent landscapes influence Univasc?

Expires for Univasc patent protections in key markets generally occurred between 2015 and 2020. Generic versions have entered many markets, eroding sales. No recent regulatory filings are reported for new formulations or indications.

In some regions, patent disputes or exclusivity extensions could influence market entry of competitors, but standard patent expiry is the primary factor.

Summary of key data points

Aspect	Data
Market Value (2022)	USD 7.2 billion
Projected CAGR (2023–2030)	3.5%
Global Market Share (est.)	<5% of ACE inhibitors
Leading players	Merck (Ramipril), Novartis (Lisinopril)
Patent expiry	2015–2020 in major markets

Key takeaways

• Univasc is an established ACE inhibitor with stability in treating hypertension and heart failure.
• The drug faces declining exclusivity and strong competition from generics.
• Market growth is steady but limited without new indications or formulations.
• Future success relies on repositioning or niche markets, not on broad market expansion.
• Strategic positioning should consider the competitive landscape, patent status, and regional adoption barriers.

FAQs

1. Will Univasc regain market share in the future?
Unlikely without new indications or formulations, as the ACE inhibitor market is saturated, and generic competition dominates.

2. Are there ongoing trials to expand Univasc indications?
No publicly listed advanced clinical trials for Univasc are ongoing; research focus appears to have shifted toward other ACE inhibitors or drug classes.

3. How does Univasc’s safety profile compare with other ACE inhibitors?
It shares similar adverse events, including cough, hyperkalemia, and angioedema, which limits differentiation.

4. What are potential markets for Univasc's specialty use?
Limited data suggest potential for combination therapies or use in hypertensive subpopulations, but no significant pipeline exists.

5. Is Univasc vulnerable to patent challenges?
Generic entry following patent expiry in key markets has already diminished exclusivity, but any patent disputes are not currently reported.

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Sources

1. MarketWatch. "ACE Inhibitors Market Size & Share 2022."
2. U.S. Food & Drug Administration. "Drug Approvals and Labeling."
3. IQVIA. "Prescription Trends and Market Share Data," 2022.