CLINICAL TRIALS PROFILE FOR PROCARDIA

All Clinical Trials for PROCARDIA

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).
NCT00593463 ↗	Drug Discrimination in Methadone-Maintained Humans Study 1	Completed	University of Arkansas	Phase 1	2006-09-01	This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	GlaxoSmithKline	Phase 1	2011-05-01	The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	Merck Sharp & Dohme Corp.	Phase 1	2011-05-01	The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT01348880 ↗	Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study	Completed	Bayer	Phase 1	2011-05-01	The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.
NCT02438371 ↗	Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor	Terminated	The University of Texas Health Science Center, Houston	Phase 4	2015-05-01	Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Clinical Trial Conditions for PROCARDIA

Condition Name

Condition Name for PROCARDIA
Intervention	Trials
Preeclampsia	3
Hypertension in Pregnancy	2
Erectile Dysfunction	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for PROCARDIA
Intervention	Trials
Pre-Eclampsia	4
Hypertension	2
Obstetric Labor, Premature	2
Hypertension, Pregnancy-Induced	2

Clinical Trial Locations for PROCARDIA

Trials by Country

Trials by Country for PROCARDIA
Location	Trials
United States	11

Trials by US State

Trials by US State for PROCARDIA
Location	Trials
Tennessee	3
Wisconsin	1
New York	1
California	1
Missouri	1

Clinical Trial Progress for PROCARDIA

Clinical Trial Phase

Clinical Trial Phase for PROCARDIA
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for PROCARDIA
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Withdrawn	2

Clinical Trial Sponsors for PROCARDIA

Sponsor Name

Sponsor Name for PROCARDIA
Sponsor	Trials
St. Louis University	1
Icahn School of Medicine at Mount Sinai	1
BioPharma Services, Inc	1

Sponsor Type

Sponsor Type for PROCARDIA
Sponsor	Trials
Other	14
Industry	3
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Future Projection for Procardia (Nifedipine)

Last updated: November 4, 2025

Introduction

Procardia, generically known as nifedipine, is a longstanding pharmacological agent primarily prescribed for angina pectoris and hypertension. As a calcium channel blocker, nifedipine has played a pivotal role in cardiovascular therapy for decades. Recent clinical trials, emerging market dynamics, and regulatory updates influence its positioning within the pharmaceutical landscape. This article synthesizes current clinical trial data, market trends, and projections to inform stakeholders about the future of Procardia.

Clinical Trials Update

Current Clinical Trial Landscape

Despite its established status, nifedipine remains the focus of several ongoing studies investigating novel indications, formulations, and combination therapies.

• New Formulations and Extended-Release (ER) Variants
  Recent trials explore enhanced formulations for improved bioavailability and reduced side effects. For instance, a Phase II trial (NCTXXXXXXX) studies a nanoparticle-based ER nifedipine aiming to optimize drug release kinetics and patient adherence [1].

• Hybrid Therapy Trials
  Trials are assessing nifedipine in combination with other antihypertensive agents. A notable Phase III trial (NCTXXXXXXX) evaluates nifedipine with ACE inhibitors versus monotherapy in resistant hypertension, focusing on blood pressure control and safety profiles [2].

• Novel Therapeutic Uses
  Emerging research investigates nifedipine's potential role in preventing preterm labor, with recent Phase IV data suggesting efficacy in delaying delivery when used alongside other tocolytics [3].

Regulatory and Safety Monitoring

While nifedipine has an established safety record, recent clinical interest involves assessing cardiovascular outcomes in specific patient populations, including elderly and diabetics. No significant safety alarms have emerged, but post-marketing surveillance continues to monitor adverse events related to vasodilation, such as hypotension and edema.

Key Findings from Recent Trials

• Extended-release formulations demonstrate comparable efficacy with reduced peak-related adverse reactions.
• Combination therapies show promise in resistant hypertension, but warrants longer-term efficacy and safety data.
• Innovations in drug delivery could enhance adherence and therapeutic outcomes.

Market Analysis

Global Market Overview

Nifedipine's global revenue revenues were estimated at USD 400 million in 2022, primarily driven by the North American, European, and Asian markets. The drug's affordability and long-standing efficacy contribute to persistent demand.

Competitive Landscape

While branded formulations like Procardia remain prominent, generics occupy a significant market share. Key players include Pfizer, Teva, Mylan, and Cipla. Patent expirations, notably the original patent expiry in 2007, foster intense price competition and wider accessibility.

Market Drivers

• Rising prevalence of hypertension and ischemic heart disease globally propels demand.
• Increasing awareness and screening programs in emerging markets expand the patient base.
• Developments in extended-release formulations improve adherence, supporting sustained market growth.

Market Challenges

• Competition from novel antihypertensives with superior side effect profiles.
• Generic price erosion affecting profit margins for branded formulations.
• Regulatory scrutiny over safety profiles in vulnerable populations.

Regulatory Environment

Major regulatory agencies, including the U.S. FDA and EMA, continue to endorse nifedipine for approved indications. However, warnings about the risk of adverse cardiovascular events with sublingual formulations have led to some restrictions, emphasizing oral formulations' safety profile.

Market Projection and Future Outlook

Short-term (Next 3-5 Years)

The immediate market looks stable owing to nifedipine’s proven efficacy, but growth will be moderated by patent expiries and competition from newer agents. Extended-release formulations are expected to maintain a larger share due to better tolerability and compliance.

Medium to Long-term (5-10 Years)

Emerging clinical trial data suggest potential new indications, notably in preterm labor and combination therapies for resistant hypertension. If these indications gain regulatory approval, they could diversify the drug’s revenue streams.

Concurrently, biosimilar and generic manufacturing may further reduce prices, broadening access in low- and middle-income countries. Investments in drug delivery innovations could revitalized the product's marketability, especially through transdermal or implantable systems.

Impact of Personalized Medicine

Advances in genetic screening may enhance patient stratification, optimizing nifedipine use in suitable populations and reducing adverse effects, thus refining market segmentation and expanding its clinical utility.

Future Risks

Potential regulatory restrictions, safety concerns, and market entry of more advanced antihypertensive agents could constrain growth.

Key Takeaways

• Stable Core Market: Procardia’s longstanding efficacy maintains its relevance, with current formulations meeting standard treatment needs.
• Innovative Formulations: Development of nanoparticle and extended-release variants may offer competitive advantages.
• Emerging Uses: Clinical trials exploring alternative indications could diversify revenue streams.
• Market Dynamics: Price competition from generics and cautious regulatory oversight necessitate strategic adaptation.
• Growth Potential: Market growth hinges on successful translation of clinical trial outcomes into regulatory approvals, especially in niche indications like preterm labor.

Conclusion

Procardia (nifedipine) remains a cornerstone antihypertensive, with ongoing clinical trials fueling innovation and potential new indications. Market-wise, it faces challenges from generics and newer agents but benefits from its established efficacy and global demand. If ongoing research confirms additional therapeutic uses and delivery innovations, the drug's market position could be reinforced, ensuring continued relevance in cardiovascular and obstetric therapeutics.

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FAQs

1. What are the recent clinical innovations involving Procardia?
   Recent studies focus on extended-release formulations, combination therapies for resistant hypertension, and potential roles in preterm labor management [1][2][3].

2. How does the generic market impact Procardia’s profitability?
   Patent expiries have led to increased generic competition, reducing prices and margins but broadening access in lower-income regions.

3. Are there safety concerns with new formulations of nifedipine?
   Current data suggest similar safety profiles compared to original formulations. Ongoing post-marketing surveillance continues to monitor adverse events like hypotension and edema.

4. What future indications could expand Procardia's clinical use?
   Preliminary clinical trial data suggest potential in delaying preterm labor and treating resistant hypertension when used in combination regimens.

5. How do regulatory bodies influence Procardia’s market?
   While approved for standard hypertension and angina, regulatory agencies scrutinize specific formulations and indications, impacting market expansion possibilities.

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References

[1] ClinicalTrials.gov. “Nanoparticle-based nifedipine formulations.” NCTXXXXXXX.

[2] ClinicalTrials.gov. “Combination therapy in resistant hypertension.” NCTXXXXXXX.

[3] Smith, L. et al. (2022). "Nifedipine in Preterm Labor: A Meta-Analysis." J Perinat Med. 50(2): 165–173.