Caverject

(Alprostadil)

ApprovedSmall molecule

Alprostadil is used to treat erectile dysfunction in men by relaxing blood vessels and increasing blood flow to the penis. It can also be used to treat certain circulatory problems and to keep blood vessels open in newborns with heart defects.[2] Caverject is currently approved and in use across 21 indications[4].[1]

Caverject is one of 477 small molecule programs targeting Adult Acute Respiratory Distress Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

476

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Adult Acute Respiratory Distress SyndromeApproved

Cardiovascular DiseaseActive, not recruiting

Erectile DysfunctionActive, not recruiting

Anterior Ischemic Optic NeuropathyApproved

IschemiaActive, not recruiting

Macular DegenerationApproved

Sexual DysfunctionApproved

Patent Ductus ArteriosusActive, not recruiting

Diabetes MellitusActive, not recruiting

Peripheral Arterial DiseaseApproved

Adult Acute Respiratory Distress SyndromeApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Erectile DysfunctionApproved

Active, not recruiting

Anterior Ischemic Optic NeuropathyApproved

Approved

IschemiaApproved

Active, not recruiting

Macular DegenerationApproved

Approved

Sexual DysfunctionApproved

Approved

Patent Ductus ArteriosusApproved

Active, not recruiting

Diabetes MellitusPreclinical

Active, not recruiting

Peripheral Arterial DiseaseApproved

Approved

Showing 10 of 21 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Caverject

VViatris Specialty LLC

Approved

19 2

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 3

Tricor

JJagotec

Preclinical

1 4

Nadroparin

GSK

Preclinical

1 5

Achromycin V

WWyeth-Lederle Vaccines

Aprotinin

1 7

Interferon-Gamma

SSPP Pharmaclon Ltd.

Preclinical

1 8

Antihypertensive Agents

NNational Heart, Lung, and Blood Institute (NHLBI)

Preclinical

1 9

Conventional

PPopulation Health Research Institute

Preclinical

1 10

Antithrombin-III

Octapharma

Preclinical

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

Timeline

Expected Milestones

Q4 2030

Phase 3Not yet recruiting

Heart Failure

NCT00610051

Clinical

Trials by Indication[1]

Erectile Dysfunction2 trials

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00080808·111 enrolled

Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction

Withdrawn·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT01776320

Efficacy2 trials

Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI

Unknown status·RRenJi Hospital·Phase 4·NCT03252665·600 enrolled

Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP

Completed·RRenJi Hospital·Phase 4·NCT03296670·57 enrolled

Anticoagulant1 trial

PGE1 as Additive Anticoagulant in ECMO-Therapy

Terminated·TThomas Staudinger·Phase 2·NCT02895373·50 enrolled

Heart Failure1 trial

ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure

Not yet recruiting·BBiopeutics Co., Ltd·Phase 3·NCT00610051·600 enrolled

Acute Kidney Injury1 trial

The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury

Unknown status·SShengjing Hospital·Phase 4·NCT03892447·300 enrolled

12 more indications

Acute1 trial

Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow

Terminated·TThe Hospital for Sick Children·Phase 1·NCT04054115·10 enrolled

Intermittent Claudication1 trial

Prostaglandin E1 in Outpatients With Intermittent Claudication

Completed· UCB logo

UCB·Phase 3·NCT01263925·561 enrolled

Female1 trial

Topical Alprostadil for Female Sexual Arousal Disorder

Completed·VVIVUS LLC·Phase 2·NCT00324948·300 enrolled

Microcirculation1 trial

Evaluation of Nail Fold Microcirculation in CKD

Unknown status·TThe Affiliated Hospital of Xuzhou Medical University·Phase 4·NCT03682952·100 enrolled

Arteriosclerosis Obliterans1 trial

A Safety/Efficacy Study of Alprostadil Liposomes for Injection to Treat Lower Extremity Arteriosclerosis Obliterans

Unknown status·GGuangzhou Yipinhong Pharmaceutical CO.,LTD·Phase 2·NCT02877173·160 enrolled

Systemic Sclerosis1 trial

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Completed·NNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)·Phase 2·NCT02228850·35 enrolled

Surgery1 trial

Blood Flow Change After Free Flap Surgery in Diabetic Patients

Completed·—··NCT03027219·44 enrolled

Ischemia1 trial

Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.

Unknown status·—·Phase 4·NCT04312555·30 enrolled

Prostate Cancer1 trial

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

Terminated·—·Phase 3·NCT00544076·110 enrolled

Arterial Occlusive Disease1 trial

Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV

Completed· UCB logo

UCB·Phase 4·NCT00596752·840 enrolled

Ischemic stroke1 trial

Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke

Unknown status·TThe First Hospital of Jilin University·Phase 4·NCT03252626·950 enrolled

Unspecified1 trial

Alprostadil in Maculopathy Study (AIMS)

Terminated· UCB logo

UCB·Phase 3·NCT00619229·37 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PROSTIN VR PEDIATRIC

NDA NDA018484

Jun 27, 1996

CAVERJECT

NDA NDA020379

Nov 19, 1996

MUSE

NDA NDA020700

Jun 12, 1997

EDEX

NDA NDA020649

Oct 31, 1997

CAVERJECT

NDA NDA020755

Jun 11, 2002

CAVERJECT IMPULSE

NDA NDA021212

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Alprostadil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Caverject drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alprostadil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alprostadil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021212). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Prostanoid EP2 Receptor Agonist; Prostanoid EP1 Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Caverject

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2030

Trials by Indication[1]

Erectile Dysfunction2 trials

Efficacy2 trials

Anticoagulant1 trial

Heart Failure1 trial

Acute Kidney Injury1 trial

Acute1 trial

Intermittent Claudication1 trial

Female1 trial

Microcirculation1 trial

Arteriosclerosis Obliterans1 trial

Systemic Sclerosis1 trial

Surgery1 trial

Ischemia1 trial

Prostate Cancer1 trial

Arterial Occlusive Disease1 trial

Ischemic stroke1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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