Procardia

(Nifedipine)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Nifedipine is used to treat high blood pressure and a type of chest pain called angina. It helps relax blood vessels so blood can flow more easily through your body.[2] Procardia is currently approved and in use across 23 indications[4].[1]

Procardia is one of 375 small molecule programs targeting Coronary Vasospasm. It is currently in Approved.

Indications

Total Trials

Active Trials

374

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary VasospasmActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Hypertension, Pregnancy-InducedActive, not recruiting

Angina PectorisActive, not recruiting

EpilepsyApproved

Partial EpilepsyApproved

Pulmonary HypertensionApproved

Preterm Premature Rupture of the MembranesApproved

Placenta PraeviaApproved

Premature BirthApproved

Coronary VasospasmApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Hypertension, Pregnancy-InducedPreclinical

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

EpilepsyApproved

Approved

Partial EpilepsyApproved

Approved

Pulmonary HypertensionApproved

Approved

Preterm Premature Rupture of the MembranesApproved

Approved

Placenta PraeviaApproved

Approved

Premature BirthApproved

Approved

Showing 10 of 23 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Procardia

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 2

Statins

Sanofi

Preclinical

1 3

Rayaldee

OOrganon and Co

Preclinical

1 4

SARS-COV-2 VACCINE

Moderna

Preclinical

2 5

Blood Taken

HHospices Civils de Lyon

Preclinical

1 6

Olokizumab

UCB

Preclinical

1 7

Disease-Modifying Anti-Rheumatic Drugs

Roche

Preclinical

1 8

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Preclinical

1 9

Covid Infection

KKing's College London

Preclinical

1 10

Standard Preparation

LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

ApprovedNot yet recruiting

Hemorrhoids

NCT07659665

Q4 2027

Post-ApprovalRecruiting

Hypertension

NCT05139238

Phase 3Recruiting

Hypertension

NCT05551104

Q3 2028

Recruiting

Lactating Women on Select DOI

NCT03511118

Q4 2029

PreclinicalRecruiting

Hypertension

NCT07363343

Clinical

Trials by Indication[1]

Preterm Labor15 trials

Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.

Completed·SStanford University·N/A·NCT00185952·70 enrolled

Two Dose Regimens of Nifedipine for the Management of Preterm Labor

Terminated·—·Phase 3·NCT00137501·102 enrolled

Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

Completed·SStanford University·Phase 1/2·NCT00486824·29 enrolled

Show 12 more trials

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT02438371·49 enrolled

Transdermal Nitroglycerin and Nifedipine in Preterm Labor

Completed·SShiraz University of Medical Sciences·Phase 4·NCT02583633·112 enrolled

Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

Completed·UUniversity of California, Irvine·N/A·NCT03129945·36 enrolled

Nifedipine Compared to Atosiban for Treating Preterm Labor

Completed·RRaed Salim·Phase 4·NCT00599898·145 enrolled

Nifedipine Treatment in Preterm Labor

Withdrawn·HHospital Clinico Universitario de Santiago·Phase 3·NCT01314859

Tocolytic Therapy for Preterm Labor in Multiple Gestation

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 3·NCT02725736·140 enrolled

Vaginal Indomethacin for Preterm Labor

Unknown status·HHadassah Medical Organization·Phase 2/3·NCT04404686·300 enrolled

Tocolysis for Preterm Labor

Completed·UUniversity of Mississippi Medical Center·N/A·NCT00811057·301 enrolled

The Efficacy of Nifedipine in the Management of Preterm Labor

Unknown status·—··NCT04644354·444 enrolled

Nifedipine for Acute Tocolysis of Preterm Labor

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT02132533·88 enrolled

Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor

Completed·—·Phase 4·NCT03040752·200 enrolled

Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

Completed·IIndiana University··NCT02090920·20 enrolled

Hypertension10 trials

Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension

Unknown status·—·Phase 3·NCT02426177·98 enrolled

Postpartum Hypertension Study

Recruiting·—·Phase 4·NCT05139238·104 enrolled

Treatment Targets for Chronic Hypertension in Pregnancy

Withdrawn·WWeill Medical College of Cornell University·Phase 1/2·NCT00194974

Show 7 more trials

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy

Completed·AAdebayo Joshua Adeniyi·N/A·NCT04435210·69 enrolled

Treatment of Hypertension With Adalat® in Combination With Other Drugs

Completed· Bayer logo

Bayer··NCT01118286·4,497 enrolled

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

Recruiting·LLoma Linda University·Phase 3·NCT05551104·500 enrolled

Persistent Postpartum Hypertension Pilot Trial

Terminated·—·Phase 4·NCT04349124·12 enrolled

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Completed·GGynuity Health Projects·Phase 4·NCT01912677·894 enrolled

Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NEPHRON)

Recruiting·TThe Cleveland Clinic·Preclinical·NCT07363343·200 enrolled

Magnesium Sulfate6 trials

Calcium Channel Blockers Compared to Magnesium Sulfate in Fetal Cerebral Blood Flow

Completed·KKasr El Aini Hospital·Phase 2/3·NCT02591004·130 enrolled

The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

Unknown status·KKonya Meram State Hospital·N/A·NCT05520021·30 enrolled

Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa

Completed·—·Phase 3·NCT03542552·176 enrolled

Show 3 more trials

Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs

Unknown status·—·N/A·NCT05345132·264 enrolled

Nifedipine Versus Magnesium Sulfate for Late Preterm Tocolysis

Unknown status·—·N/A·NCT05343806·264 enrolled

Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

Completed·SStanford University·N/A·NCT00185900·192 enrolled

Chronic Kidney Disease4 trials

Sitaxsentan in Proteinuric Chronic Kidney Disease

Completed·UUniversity of Edinburgh·Phase 2·NCT00817037·27 enrolled

Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

Completed· Pfizer logo

Pfizer·Phase 2·NCT00810732·27 enrolled

Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study

Completed· Bayer logo

Bayer··NCT03194633·871 enrolled

Show 1 more trial

Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Completed· Bayer logo

Bayer··NCT01363336·1,882 enrolled

Hypertensive3 trials

Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

Withdrawn·SSt. Louis University·N/A·NCT02933593

PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

Not yet recruiting·UUniversity of California, Los Angeles·Phase 4·NCT06915792·110 enrolled

Response to Anti-hypertensives in Pregnant and Postpartum Patients

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03506724·109 enrolled

43 more indications

Pregnancy3 trials

Early Vascular Adjustments During Hypertensive Pregnancy

Unknown status·MMaastricht University Medical Center·Phase 4·NCT02531490·368 enrolled

Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy

Recruiting·MMarshall University··NCT04755764·60 enrolled

Treatment of Elevated Blood Pressures in Early Pregnancy

Terminated·MMarshall University·Phase 2·NCT05955040·2 enrolled

Preterm Delivery3 trials

The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

Completed·IIndonesia University·Phase 4·NCT03005496·56 enrolled

Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

Terminated·TThe Baruch Padeh Medical Center, Poriya·N/A·NCT00525486

Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery

Withdrawn·IInstituto de Investigacion Sanitaria La Fe·Phase 3·NCT01796522

Preeclampsia3 trials

Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT01351428·20 enrolled

Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor

Completed·OOhio State University·Phase 4·NCT04392375·110 enrolled

Impedance Cardiography to Decrease the Risk of Preeclampsia

Withdrawn·UUniversity of Tennessee Medical Center·Phase 1·NCT03245970

Fed3 trials

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Completed· Bayer logo

Bayer·Phase 3·NCT01294215·72 enrolled

High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Completed· Bayer logo

Bayer·Phase 3·NCT01287260·352 enrolled

Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

Unknown status·CCao Yu·Phase 1·NCT04438720·60 enrolled

Blood Pressure Variability2 trials

The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese

Unknown status·FFirst Affiliated Hospital of Harbin Medical University·Phase 2/3·NCT02513927·40 enrolled

The Effects of Doxazosin and Nifedipine on Blood Pressure Variability and Uric Acid in Plasma in Hypertensive Patients

Unknown status·FFirst Affiliated Hospital of Harbin Medical University·Phase 2/3·NCT02563405·30 enrolled

Single Dose2 trials

Bioavailability Of A Single Dose Of Nifedipine Oral Solution Compared To Adalat Capsules In Healthy Female Volunteers

Completed·RReig Jofre Group·Phase 1·NCT02071589·36 enrolled

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions

Completed·SSocraTec R&D GmbH·Phase 1·NCT00884442·28 enrolled

Pulmonary Edema2 trials

Evaluating the Utility of Continuous Positive Airway Pressure in the Treatment of High Altitude Pulmonary Edema

Completed·CCommonSpirit Health·N/A·NCT04186598·64 enrolled

Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Unknown status·MMassachusetts General Hospital·N/A·NCT04288219·16 enrolled

Treatment2 trials

Raynaud's Treatment Study (RTS)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000530

Nifedipine Treatment on Uterine Contractility in IVF

Unknown status·HHadassah Medical Organization·Phase 2·NCT02072291·90 enrolled

Atrial Fibrillation1 trial

Nifedipine vs Telmisartan on Prevention of Atrial Fibrillation (AF) Recurrence in Hypertensive Patients With AF

Completed·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT01435161·160 enrolled

Randomised Controlled Trial1 trial

Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial

Unknown status·Nnor zila hassan malek·Phase 2·NCT01985594·32 enrolled

Function1 trial

Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery

Completed·UUniversity of Oslo School of Pharmacy·Phase 4·NCT00244530·20 enrolled

Intravenous1 trial

Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine

Unknown status·SSohag University·N/A·NCT06265415·60 enrolled

Pre-Term1 trial

Nifedipine Pharmacokinetics and Pharmacodynamics When Used as a Tocolytic in Acute Threatened Preterm Labour

Unknown status·CChantal Csajka·Phase 4·NCT02068404·75 enrolled

Oral1 trial

Oral Nifedipine Versus Oral Labetalol

Completed·—·N/A·NCT02168309·50 enrolled

Completed·UUniversity Hospital, Rouen·Phase 2·NCT00620724·109 enrolled

Myalgia1 trial

A Study Examining the Use of Vaginal Nifedipine With Pelvic Floor Physical Therapy for Levator Myalgia and Pelvic Pain

Withdrawn·VVanderbilt University·N/A·NCT01586286

Genetic Polymorphism1 trial

Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

Unknown status·NNatalia Valadares de Moraes·Phase 4·NCT03710395·19 enrolled

Iron Overload1 trial

Oral Nifedipine to Treat Iron Overload

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 1·NCT00712738·6 enrolled

Nephropathy1 trial

Endothelin Receptor Antagonism in Proteinuric Nephropathy

Completed·UUniversity of Edinburgh·Phase 1·NCT00722215·22 enrolled

Ischemia1 trial

Asymptomatic Cardiac Ischemia Pilot (ACIP) Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000478

Premature rupture of membranes1 trial

Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03976063·850 enrolled

Vascular Function1 trial

Role of Calcium Channels in Vascular Function

Completed·UUniversity of Southern Denmark·N/A·NCT02885558·12 enrolled

Effectiveness1 trial

Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01167153·564 enrolled

Cardiovascular1 trial

HIGH Altitude CArdiovascular REsearch in the ANDES

Completed·IIstituto Auxologico Italiano·Phase 4·NCT01830530·100 enrolled

Methadone1 trial

Drug Discrimination in Methadone-Maintained Humans Study 1

Completed·UUniversity of Arkansas·Phase 1·NCT00593463·40 enrolled

Ibuprofen1 trial

Treating Postictal Symptoms Using Ibuprofen and Nifedipine

Recruiting·UUniversity of Calgary·Phase 2·NCT03949478·90 enrolled

ESS1 trial

FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)

Completed· Bayer logo

Bayer·Phase 4·NCT01071122·365 enrolled

Interaction1 trial

Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT03100838·64 enrolled

Eclampsia1 trial

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Unknown status·SServices Institute of Medical Sciences, Pakistan·Phase 2/3·NCT03325348·194 enrolled

Altitude1 trial

Three New Ideas to Protect Special Forces From the Stress of High Altitude

Completed·UUniversity of Colorado, Denver·Phase 4·NCT02463357·148 enrolled

Exercise1 trial

Choroidal Blood Flow Regulation During Isometric Exercise: Effects of Ca2+-Channel Blockade

Completed·MMedical University of Vienna·N/A·NCT00280462·21 enrolled

Essential Hypertension1 trial

Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension

Completed· Bayer logo

Bayer·Phase 4·NCT01518855·514 enrolled

Hemodialysis1 trial

The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis

Unknown status·GGuangzhou First People's Hospital·Phase 4·NCT01021501·20 enrolled

COVID-191 trial

Medicine-induced Cardiac Hemodialysis on COVID-19

Completed·YYang I. Pachankis·Phase 4·NCT05711810·1 enrolled

Obese Patients1 trial

Use of Impedance Cardiography to Decrease the Risk of Pre-eclampsia in Obese Patients

Unknown status·UUniversity of Tennessee Graduate School of Medicine·Phase 1·NCT03105661·400 enrolled

Anal fissure1 trial

The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure

Completed·RRDD Pharma Ltd·Phase 2/3·NCT02527109·339 enrolled

Blood Pressure1 trial

Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.

Completed· Bayer logo

Bayer·Phase 4·NCT02413515·278 enrolled

Indomethacin1 trial

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Unknown status·SSaint Thomas Hospital, Panama·Phase 3·NCT01360034·216 enrolled

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Hemorrhoids1 trial

The Effect of Oral Nifedipine Versus Placebo on Postoperative Pain and Healing Following Hemorrhoidectomy in Adult Patients: A Randomized Controlled Trial in Sana'a, Yemen

Not yet recruiting·SSana'a University·Approved·NCT07659665·100 enrolled

Unspecified2 trials

Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

Unknown status·UUnited States Naval Medical Center, San Diego·Phase 3·NCT00713739·240 enrolled

High Dose BAYA1040 CR: a Long Term Extension Study

Completed· Bayer logo

Bayer·Phase 3·NCT01355367·120 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PROCARDIA

NDA NDA018482

Nov 27, 1985

ADALAT

NDA NDA019478

Sep 6, 1989

PROCARDIA XL

NDA NDA019684

Apr 21, 1993

ADALAT CC

NDA NDA020198

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Nifedipine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Procardia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nifedipine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nifedipine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020198). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Gated L-Type Calcium Channel Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Procardia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q3 2028

Q4 2029

Trials by Indication[1]

Preterm Labor15 trials

Hypertension10 trials

Magnesium Sulfate6 trials

Chronic Kidney Disease4 trials

Hypertensive3 trials

Pregnancy3 trials

Preterm Delivery3 trials

Preeclampsia3 trials

Fed3 trials

Blood Pressure Variability2 trials

Single Dose2 trials

Pulmonary Edema2 trials

Treatment2 trials

Atrial Fibrillation1 trial

Randomised Controlled Trial1 trial

Function1 trial

Intravenous1 trial

Pre-Term1 trial

Oral1 trial

Congenital Adrenal Hyperplasia1 trial

Type 2 Diabetes1 trial

Conservative Management1 trial

Myalgia1 trial

Genetic Polymorphism1 trial

Iron Overload1 trial

Nephropathy1 trial

Ischemia1 trial

Premature rupture of membranes1 trial

Vascular Function1 trial

Effectiveness1 trial

Cardiovascular1 trial

Methadone1 trial

Ibuprofen1 trial

ESS1 trial

Interaction1 trial

Eclampsia1 trial

Altitude1 trial

Exercise1 trial

Essential Hypertension1 trial

Hemodialysis1 trial

COVID-191 trial

Obese Patients1 trial

Anal fissure1 trial

Blood Pressure1 trial

Indomethacin1 trial

Lactating Women on Select DOI1 trial

Hemorrhoids1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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