CLINICAL TRIALS PROFILE FOR NIFEDIPINE

All Clinical Trials for Nifedipine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000478 ↗	Asymptomatic Cardiac Ischemia Pilot (ACIP) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-11-01	To assess the feasibility of and test the methodology for a full-scale clinical trial of therapies for asymptomatic cardiac ischemia.
NCT00000530 ↗	Raynaud's Treatment Study (RTS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1992-09-01	To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.
NCT00000936 ↗	A Study To Test An Anti-Rejection Therapy After Kidney Transplantation	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1999-11-01	Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	Hennepin County Medical Center, Minneapolis	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00004266 ↗	Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1993-08-01	OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria. III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for Nifedipine

Condition Name

Condition Name for Nifedipine
Intervention	Trials
Hypertension	32
Hypertension in Pregnancy	11
Preterm Labor	10
Preeclampsia	7

Condition MeSH

Condition MeSH for Nifedipine
Intervention	Trials
Hypertension	59
Obstetric Labor, Premature	32
Premature Birth	25
Pre-Eclampsia	24

Clinical Trial Locations for Nifedipine

Trials by Country

Trials by Country for Nifedipine
Location	Trials
United States	98
China	30
United Kingdom	22
Italy	22
Spain	15

Trials by US State

Trials by US State for Nifedipine
Location	Trials
California	10
Texas	7
Ohio	7
Tennessee	6
North Carolina	5

Clinical Trial Progress for Nifedipine

Clinical Trial Phase

Clinical Trial Phase for Nifedipine
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
Phase 4	50

Clinical Trial Status

Clinical Trial Status for Nifedipine
Clinical Trial Phase	Trials
Completed	83
Unknown status	32
Recruiting	22

Clinical Trial Sponsors for Nifedipine

Sponsor Name

Sponsor Name for Nifedipine
Sponsor	Trials
Bayer	18
Assiut University	5
RDD Pharma Ltd	4

Sponsor Type

Sponsor Type for Nifedipine
Sponsor	Trials
Other	181
Industry	42
NIH	8

Nifedipine Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is the current clinical development and trial footprint for nifedipine?

Nifedipine is an established antihypertensive and antianginal drug. Clinical activity is dominated by generics and formulation work (e.g., extended-release versions) rather than new molecular-entity development. The observable trial footprint in public registries is therefore largely centered on:

• Bioequivalence and formulation comparability studies (including modified-release versions)
• Short interventional studies in labeled indications (hypertension, stable angina, vasospastic angina) and adjunct endpoints
• Post-authorization studies, including tolerability and pharmacokinetic characterizations

Key point for decision-makers: nifedipine’s clinical pipeline is not a typical “new drug” pipeline; it is a sustained stream of formulation-level and comparative studies that supports supply, product switching, and market share within generic and branded generics.

Where are nifedipine trials most commonly registered?

Trial registration and reporting for nifedipine are most often visible through global registries that capture:

• Interventional studies (small-to-mid scale; often pharmacokinetic/pharmacodynamic or bioequivalence)
• Observational and real-world studies that evaluate dosing patterns and outcomes

The overall pattern in registries is consistent: low novelty, frequent studies tied to product variants rather than therapeutic concept innovation.

What does this imply for near-term clinical differentiation?

Because nifedipine is already approved and widely used, differentiation is typically achieved through:

• Controlled-release/modified-release technology (to flatten plasma exposure)
• Dose-form factors (titration convenience, tablet splitting characteristics, patient adherence support)
• Manufacturing and formulation updates that enable market entry or product replacement under regulatory requirements

Actionable takeaway: near-term competitive advantage is more likely to come from formulation and regulatory execution than from substantive new efficacy claims.

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How big is the nifedipine market today, and what drives demand?

Nifedipine is a calcium channel blocker used broadly for:

• Hypertension
• Chronic stable angina
• Vasospastic (Prinzmetal) angina
• Off-label use patterns that vary by country and guideline framework

Demand drivers

1. Widespread guideline inclusion of calcium channel blockers for hypertension and angina
2. Generic availability that expands volume but compresses pricing
3. Physician familiarity and established safety profile, which sustains prescribing
4. Population aging and the prevalence of hypertension in major markets
5. Formulation-level substitution (immediate-release to modified-release and between brands/generics)

Market structure

• Pricing is competitive and is typically lower than newer cardiometabolic agents.
• Revenue is volume-led, with growth tied to population and prescribing rates more than to therapy adoption.

Benchmarks from public pricing and drug-utilization datasets Broad drug classification views from global reference sources place nifedipine among widely used oral calcium channel blockers in cardiovascular pharmacotherapy categories. Use intensity remains sustained relative to other older antihypertensives due to entrenched clinical use. (See cited sources: [1], [2].)

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What is the competitive landscape and pricing pressure profile?

How does generic competition shape market economics?

Nifedipine’s economics reflect classic older-drug dynamics:

• Many suppliers across dosage strengths
• Frequent tendering in institutional channels
• Strong price competition in markets with established generic policies
• Brand-generic and branded generics depend on supply reliability and formulation differentiation rather than patent-based protection

Where do companies typically compete within nifedipine?

Competition concentrates around:

• Extended-release vs immediate-release positioning
• Bioequivalence readiness and speed-to-market in regulated channels
• Local formulary access and reimbursement rules
• Manufacturing scale and compliance track record

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What is the most likely market trajectory (forecast) for nifedipine?

Because nifedipine is mature, forecasts should be framed as volume growth with price pressure, rather than step-change therapeutic expansion.

Base-case projection logic

• Volume: modest growth supported by demographics and stable guideline use
• Price: continuing erosion or stagnation tied to generic competition
• Revenue: grows slower than units; margins remain thin

Indicative outlook (directional)

• Near term (1-3 years): stable demand, continued substitution among generics, localized supply-driven volatility
• Mid term (3-7 years): gradual market expansion in regions with lower penetration of cardiology services; continued price competition in high-penetration markets
• Long term (>7 years): mature saturation in developed markets; incremental growth tied to healthcare access and treatment rates in emerging markets

Key implication: A market entry or scale-up strategy for nifedipine must be underwritten by manufacturing cost advantages and regulatory throughput, not by premium pricing.

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What regulatory and evidence themes matter most for new or updated nifedipine products?

What clinical package is typical for nifedipine product changes?

For established drugs like nifedipine, regulators often rely on:

• Bioequivalence studies for generic and formulation updates
• Pharmacokinetic comparability for modified-release changes
• Safety and tolerability comparisons consistent with existing labeling
• Chemistry, manufacturing, and controls (CMC) robustness to support switching

What endpoints tend to be used?

• Pharmacokinetic parameters (Cmax, Tmax, AUC)
• Tolerability and adverse event profiles aligned with known class effects
• Blood pressure reduction measures in labeled indications when required by local rules

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How should investors and R&D leaders think about “pipeline value” for nifedipine?

Where value is likely to be created

• Faster generic entry to maximize time in a local tender or reimbursement window
• Modified-release differentiation where it supports formulary placement
• Manufacturing resiliency (avoid stockouts, reduce recalls, maintain regulatory compliance)

Where value is unlikely to be created

• New efficacy claims absent meaningful mechanism novelty
• Large-scale Phase 3 clinical programs for an already established molecule, unless driven by special regional requirements or reformulation mandates

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Nifedipine market model and projection framework

Because public sources do not provide a single consolidated, audited global revenue figure in the materials cited below, the most business-relevant approach is a scenario model that ties revenue to unit volume and net price.

Revenue equation

Revenue = Units sold × Net price

Scenario assumptions (directional)

Scenario	Unit volume trend	Net price trend	Revenue outcome
Conservative	Slight growth	Continued erosion / stagnation	Low growth / flat revenue
Base case	Modest growth	Mild erosion	Low-to-moderate revenue growth
Upside	Higher uptake via formulary wins	Slower erosion	Growth outpaces base case

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Key differentiators that can shift outcomes even in mature markets

1. Modified-release performance and tolerability fit
2. Speed-to-market in local regulatory pathways
3. Tender execution and channel contracts

These factors determine whether a company captures share in a price-compressed market.

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Key Takeaways

• Nifedipine clinical activity is dominated by formulation and comparability studies, not new-molecule development.
• The market is mature and volume-led, with pricing pressure driven by extensive generic supply.
• Near-term trajectory is stable demand with revenue growth that lags unit growth due to net price erosion.
• Competitive advantage comes from formulation differentiation (especially modified-release), regulatory execution, and manufacturing and procurement reliability.
• Best-performing strategies in mature cardiology generics focus on throughput and channel access rather than novel clinical claims.

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FAQs

1) Is nifedipine still being actively studied in clinical trials?

Yes, but most registered activity is oriented around bioequivalence, formulation comparability, and short interventional or pharmacokinetic studies aligned with an already-approved therapeutic profile.

2) What drives demand for nifedipine in the real economy?

Hypertension and angina prevalence, guideline inclusion of calcium channel blockers, and entrenched prescribing patterns, with demand sustained by generic availability.

3) How does generic competition affect nifedipine pricing?

Generic competition compresses net price and drives revenue growth primarily through unit volume and formulary share rather than pricing power.

4) What product changes create the most realistic path to differentiation?

Modified-release and formulation-level updates that improve exposure profile or support tolerability and adherence, while meeting bioequivalence or regulatory comparability requirements.

5) What is the most realistic forecast shape for nifedipine?

A mature-market curve: stable-to-modest unit growth with continued net price pressure, yielding low-to-moderate revenue growth.

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References

[1] World Health Organization. (n.d.). ATC/DDD Index. https://www.whocc.no/atc_ddd_index/
[2] NLM (National Library of Medicine). (n.d.). Nifedipine Drug Information and Classification. https://pubchem.ncbi.nlm.nih.gov/