CLINICAL TRIALS PROFILE FOR PROCARDIA XL

All Clinical Trials for Procardia Xl

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.

Clinical Trial Conditions for Procardia Xl

Condition Name

Condition Name for Procardia Xl
Intervention	Trials
Preeclampsia	3
Hypertension in Pregnancy	2
Obstetric Labor, Premature	1
Chronic Hypertension Complicating Pregnancy (Diagnosis)	1

Condition MeSH

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

Clinical Trial Locations for Procardia Xl

Trials by Country

Trials by Country for Procardia Xl
Location	Trials
United States	11

Trials by US State

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

Clinical Trial Progress for Procardia Xl

Clinical Trial Phase

Clinical Trial Phase for Procardia Xl
Clinical Trial Phase	Trials
Phase 4	2
Phase 1/Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Procardia Xl
Clinical Trial Phase	Trials
Completed	5
Withdrawn	2
Terminated	2

Clinical Trial Sponsors for Procardia Xl

Sponsor Name

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

Sponsor Type

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

Procardia Xl Market Analysis and Financial Projection

Last updated: April 28, 2026

Procardia XL (nifedipine extended-release): What do the clinical-trials readouts show, and what does the market trajectory look like?

Clinical-trials update: What evidence base drives Procardia XL’s current positioning?

Procardia XL is a brand of nifedipine extended-release (ER). The product line is built on long-established efficacy of nifedipine in:

• Chronic stable angina
• Hypertension
• Vasospastic (Prinzmetal’s) angina

Publicly available “new” late-stage trials specific to Procardia XL (as a named brand) are limited. The clinical foundation used in modern prescribing and payer policy is largely derived from older nifedipine ER trials and from class-level evidence for nifedipine ER formulations, plus post-marketing safety reporting rather than recurring phase 3 brand-new efficacy studies.

What remains active in practice

• Ongoing surveillance of safety signals through pharmacovigilance rather than new phase 3 efficacy trials.
• Formulation and formulation-equivalence work in the broader nifedipine ER category, typically centered on bioequivalence and substitution, not new endpoints.

Evidence endpoints used historically for nifedipine ER Across nifedipine ER studies and label-referenced trials, the consistent clinical endpoints include:

• Angina: reduction in attack frequency and/or improved exercise tolerance measures
• Hypertension: reduction in seated systolic and diastolic blood pressure vs placebo
• Vasospasm: decreased incidence of vasospastic episodes

Practical takeaway for development If a sponsor is considering differentiation beyond the current branded product, the most plausible paths are:

• next-generation dosing or delivery with differentiated pharmacokinetics (PK),
• combination strategies (nifedipine plus a complementary class),
• new patient segmentation where current evidence is thinner (real-world practice studies), or
• formulation/PK differentiation that avoids direct head-to-head phase 3 costs.

Because Procardia XL is nifedipine ER, the bar for “trial value” is lower than for truly novel mechanisms; payers usually price off established class benefit and generic competition.

---

Market analysis: What does the market structure look like for Procardia XL and nifedipine ER?

Procardia XL faces a mature environment dominated by generics. Nifedipine ER is a well-entrenched molecule in multiple dosage forms and strengths, which compresses branded pricing and limits incremental demand growth.

Market dynamics that matter

1. Generic substitution

   • In US retail and many markets, nifedipine ER has extensive generic availability, pushing net price down over time.
   • Brand share typically erodes after patent/market exclusivity loss (the drug-class is older; Procardia brands are not treated as protected late-cycle products).

2. Class substitutability

   • Payers often treat nifedipine ER as therapeutically substitutable within ER calcium channel blocker ranges, especially where clinical practice supports equivalence.

3. Channel mix

   • Demand concentrates in chronic therapy channels where switching between generic ER products is administratively feasible.

Commercial implication For Procardia XL specifically, the market opportunity is mostly tied to:

• historical brand retention (where substitution barriers exist),
• formulary positioning in select health systems, and
• pharmacy benefit manager (PBM) contract behavior in ER calcium channel blocker classes.

Because the mechanism is mature, the market does not behave like a growth-category drug; it behaves like a volume-category commodity where net revenue is dominated by price and share.

---

Projection: What is the most likely demand and revenue trajectory for Procardia XL over the next 3 to 5 years?

A defensible projection framework for Procardia XL uses three drivers:

• Volume driver: underlying treated population for hypertension and angina, plus adherence persistence
• Price driver: generic pressure and PBM dynamics for ER CCBs
• Mix driver: shifting use across ER formulations and strengths

Directionally expected trajectory

• Demand (units): modest, near-flat to slowly declining, driven by generic substitution and ongoing switching.
• Net revenue: declining unless Procardia XL regains share through formulary exceptions or re-anchors through contract pricing.
• Share: continues to drift down in most competitive formularies where generic nifedipine ER is the default.

What would change the curve

• A sustained payer shift toward branded ER nifedipine over generics is unlikely without a differentiated outcome claim or a supply/contract disruption.
• A new clinical evidence package that supports a clearly differentiated population or a new dosing regimen would be required to justify premium positioning, but the evidence base for Procardia XL as a named brand has limited momentum.

Business conclusion Under standard market conditions for mature generics, the probability-weighted outcome for Procardia XL over 3 to 5 years is stable-to-declining volume with structurally pressured net pricing, producing declining revenue in most scenarios.

---

Regulatory and patent reality check: What does exclusivity status imply for future brand-led growth?

For mature nifedipine ER products, the business constraint is straightforward: brand-level exclusivity is not the platform for near-term growth. Most growth is either:

• new competitive protection (rare for an older molecule), or
• manufacturing and contract execution to maintain share against generics.

Because Procardia XL is a branded nifedipine ER product in a generic-dominated class, future upside depends more on distribution and payer contracting than on clinical differentiation.

---

Key Takeaways

• Clinical updates for Procardia XL are largely post-marketing and class-level rather than frequent new phase 3 readouts for the named brand.
• Market structure is generic-dominant; demand behaves like a chronic-therapy commodity with low room for premium pricing.
• 3 to 5 year outlook is most consistent with stable-to-declining volume and declining net revenue unless formulary dynamics or supply/contract terms provide temporary insulation.

---

FAQs

1) What is Procardia XL’s active ingredient and therapeutic class?

It is nifedipine extended-release, a dihydropyridine calcium channel blocker used in hypertension and angina indications.

2) Are there many new late-stage trials specifically for Procardia XL?

Publicly visible late-stage brand-specific readouts are limited; clinical positioning relies on older ER nifedipine evidence and ongoing safety surveillance.

3) How does generic entry typically affect Procardia XL economics?

It drives net price compression and share erosion, with demand shifting to lower-cost alternatives in payer and pharmacy workflows.

4) What endpoints matter most for nifedipine ER clinical efficacy?

Historically, trials use angi­na attack frequency/exercise measures and blood pressure reduction, with vasospasm episode reduction for relevant indications.

5) What would most plausibly create premium positioning for the brand?

A clearly differentiated clinical profile tied to a new evidence package, or a differentiated dosing/delivery strategy with payer-relevant outcomes.

---

References

[1] DailyMed. PROCARDIA XL (nifedipine) extended-release tablets prescribing information. https://dailymed.nlm.nih.gov
[2] US FDA. Drug Approval Reports and labeling resources for nifedipine and extended-release calcium channel blocker class context. https://www.fda.gov
[3] National Library of Medicine (NIH). ClinicalTrials.gov results for nifedipine and nifedipine ER-related studies. https://clinicaltrials.gov