Primacor

(Milrinone)

ApprovedSmall molecule

Primacor is a small molecule that works as a Phosphodiesterase 3a Inhibitor.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Primacor is one of 338 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

337

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Cerebral IschemiaActive, not recruiting

Acute Myocardial InfarctionActive, not recruiting

Pulmonary HypertensionApproved

Intracranial VasospasmApproved

Congestive Heart FailureActive, not recruiting

Myocardial IschemiaActive, not recruiting

Coronary Artery BypassActive, not recruiting

Muscle CrampApproved

Septic ShockApproved

Cardiovascular DiseaseApproved

Active, not recruiting

Cerebral IschemiaPhase 2

Active, not recruiting

Acute Myocardial InfarctionPhase 2

Active, not recruiting

Pulmonary HypertensionApproved

Approved

Intracranial VasospasmApproved

Approved

Congestive Heart FailureApproved

Active, not recruiting

Myocardial IschemiaPreclinical

Active, not recruiting

Coronary Artery BypassPreclinical

Active, not recruiting

Muscle CrampApproved

Approved

Septic ShockApproved

Approved

Showing 10 of 13 indications

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Primacor

Sanofi

Approved

2 2

Amidate

Pfizer

Preclinical

1 3

Brethine

Sanofi

Preclinical

1 4

Monoferric

PPharmacosmos A/S

Preclinical

5 5

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

4 6

Activase

Savaysa

Xifaxan

2 9

Zoloft

VViatris Specialty LLC

Preclinical

2 10

Oraverse

LLife Extension Foundation Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Cardiogenic Shock

NCT05267886

Q1 2028

N/ANot yet recruiting

MPA

NCT07144267

Q2 2029

Phase 3Recruiting

Post-Ligation Cardiac Syndrome

NCT06679855

Clinical

Trials by Indication[1]

Pulmonary Hypertension4 trials

Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Recruiting·ZZagazig University·Phase 4·NCT04484675·38 enrolled

Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

Completed·—·Phase 1/2·NCT02595541·30 enrolled

Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

Completed·RRania Ali El-Farrash·Phase 1·NCT04391478·40 enrolled

Show 1 more trial

Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children

Completed·MMuhammad Aamir Latif·N/A·NCT06562036·42 enrolled

Cardiac Surgery4 trials

Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

Unknown status·—·Phase 4·NCT05132153·70 enrolled

Milrinone on Right Ventricular Strain in Cardiac Surgery

Unknown status·KKonkuk University Medical Center··NCT06077721·41 enrolled

Milrinone Inhaled in Cardiac Surgery

Completed·AAndre Denault·Phase 2·NCT00819377·124 enrolled

Show 1 more trial

Levosimendan in Congenital Cardiac Surgery

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·N/A·NCT00695929·50 enrolled

Surgery3 trials

Levosimendan Versus Milrinone in Off Pump CABG Surgery

Unknown status·—·Phase 4·NCT03855579·60 enrolled

Two Inodilators Postsurgery in Neonates

Completed·FFundacion para la Investigacion Biomedica del Hospital Universitario la Paz·Phase 1/2·NCT01576094·20 enrolled

Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Unknown status·SShanghai Children's Medical Center·Phase 3·NCT03823781·520 enrolled

Heart Failure2 trials

Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure

Completed·TThe Alfred·Phase 1/2·NCT01956006·26 enrolled

Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

Completed·—··NCT07186062·60 enrolled

Septic Shock2 trials

Milrinone Versus Placebo in Patients With Septic Shock

Unknown status·MMahidol University·Phase 2·NCT05122884·64 enrolled

Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock

Unknown status·SSahlgrenska University Hospital·Phase 4·NCT02640846·30 enrolled

20 more indications

Cardiopulmonary Bypass2 trials

Effect of Brief Nebulization of Milrinone on Pulmonary Arterial Pressure Before Cardiopulmonary Bypass on Mitral Valve Surgery Patients

Completed·KKonkuk University Medical Center·Phase 3·NCT01621971·20 enrolled

Impact of CArdiopulmonary Bypass Flow on Renal Blood Flow, Function and OXygenation

Completed·SSahlgrenska University Hospital·N/A·NCT02549066·18 enrolled

Acute Myocardial Infarction1 trial

Concomitant Milrinone and Esmolol Treatment in Patients with Acute Myocardial Infarction

Completed·SShantou University Medical College·Phase 2·NCT02098629·25 enrolled

Congenital Heart Disease1 trial

Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?

Completed·GGöteborg University·Phase 2·NCT02232399·72 enrolled

Open Heart Surgery1 trial

Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Unknown status·LLudwig Boltzmann Gesellschaft·Phase 2·NCT00549107·40 enrolled

Hernia1 trial

Milrinone in Congenital Diaphragmatic Hernia

Completed·NNICHD Neonatal Research Network·Phase 2·NCT02951130·66 enrolled

Hepatectomy1 trial

Milrinone During Living Donor Hepatectomy

Completed·SSeoul National University Hospital·N/A·NCT00966745·38 enrolled

AIN1 trial

Dobutamaine Versus Milrinone in Cardiorenal Syndrome

Withdrawn·MMaimonides Medical Center·Phase 2·NCT02644057

Cerebral ischemia1 trial

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Recruiting·UUniversity Hospital, Toulouse·Phase 2·NCT04282629·234 enrolled

MPA1 trial

Comparison of Milrinone and Epinephrine on TAPSE

Not yet recruiting·MMansoura University·N/A·NCT07144267·102 enrolled

Coronary Artery Bypass1 trial

Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery

Unknown status·KKonkuk University Medical Center··NCT04153383·20 enrolled

Cardiogenic Shock1 trial

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

Recruiting·OOttawa Heart Institute Research Corporation·Phase 4·NCT05267886·346 enrolled

Oral1 trial

Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of a Slow Release Oral Formulation of Milrinone

Completed·TThe Alfred·Phase 1/2·NCT01849094·9 enrolled

Function1 trial

The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG

Completed·UUniversity of Luebeck·Phase 3·NCT00446017·60 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Critically Ill Patients1 trial

Milrinone Versus Dobutamine in Critically Ill Patients

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT03207165·192 enrolled

Subarachnoid Hemorrhage1 trial

Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Terminated·IIndiana University·Phase 2·NCT02712788·4 enrolled

Infusion1 trial

Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery

Terminated·JJohn M Costello·Phase 2·NCT00543309·106 enrolled

Cardiac1 trial

Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

Completed·SSahlgrenska University Hospital·N/A·NCT02408003·30 enrolled

Post-ligation Cardiac Syndrome1 trial

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Recruiting·NNICHD Neonatal Research Network·Phase 3·NCT06679855·316 enrolled

Unspecified1 trial

Evaluating Precision of Therapy - Milrinone

Completed·TThe Hospital for Sick Children·Phase 2·NCT01841177·52 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 31, 1987

PRIMACOR

NDA NDA019436

Aug 9, 1994

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA020343

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Milrinone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Milrinone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Milrinone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020343). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Phosphodiesterase 3a Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sanofi

Primacor

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q2 2029

Trials by Indication[1]

Pulmonary Hypertension4 trials

Cardiac Surgery4 trials

Surgery3 trials

Heart Failure2 trials

Septic Shock2 trials

Cardiopulmonary Bypass2 trials

Acute Myocardial Infarction1 trial

Congenital Heart Disease1 trial

Open Heart Surgery1 trial

Hernia1 trial

Hepatectomy1 trial

AIN1 trial

Cerebral ischemia1 trial

MPA1 trial

Coronary Artery Bypass1 trial

Cardiogenic Shock1 trial

Oral1 trial

Function1 trial

Blood Pressure1 trial

Critically Ill Patients1 trial

Subarachnoid Hemorrhage1 trial

Infusion1 trial

Cardiac1 trial

Post-ligation Cardiac Syndrome1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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