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Venofer

(Iron Sucrose)

ApprovedSmall molecule

AAmerican Regent, Inc.

Iron Sucrose is used to treat iron deficiency anemia in patients with chronic kidney disease, particularly those undergoing dialysis. It replaces iron that the body has lost or cannot absorb properly.[2] Venofer is currently approved and in use across 10 indications[4].[1]

Venofer is one of 293 small molecule programs targeting Fatigue. It is currently in Approved.

10

Indications

57

Total Trials

5

Active Trials

292

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Hip FractureActive, not recruiting

MortalityActive, not recruiting

Kidney DiseaseActive, not recruiting

Iron Deficiency AnemiaActive, not recruiting

Anemia (phenotype)Active, not recruiting

AnemiaActive, not recruiting

Pulmonary Arterial HypertensionApproved

Chronic Kidney DiseaseActive, not recruiting

HypoxiaActive, not recruiting

Hip FractureApproved

Active, not recruiting

MortalityApproved

Active, not recruiting

Kidney DiseasePhase 3

Active, not recruiting

Iron Deficiency AnemiaPhase 3

Active, not recruiting

Anemia (phenotype)Approved

Active, not recruiting

AnemiaPhase 2

Active, not recruiting

Pulmonary Arterial HypertensionApproved

Approved

Chronic Kidney DiseaseApproved

Active, not recruiting

HypoxiaPhase 1

Active, not recruiting

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Venofer

AAmerican Regent, Inc.

Aranesp

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Uloric

Glucotrol

Vemlidy

Activase

Flomax

Miochol

BBausch Health Americas, Inc.

Epoetin Beta

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

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Pregnancy

NCT05251493

Clinical

Trials by Indication[1]

Anemia9 trials

Erythropoietin And/Or Iron Sucrose For Perioperative Anemia Management In Hip and Knee Arthroplasty

Unknown status·PPeking Union Medical College Hospital··NCT03917394·780 enrolled

IV Iron for the Anemia of Traumatic Critical Illness

Completed·—·N/A·NCT01180894·150 enrolled

Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00660933·70 enrolled

Show 6 more trials

Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

Terminated·UUnity Health Toronto·Phase 2·NCT03528564·4 enrolled

The Benefits of a Preoperative Anemia Management Program

Terminated·UUniversity of Alabama at Birmingham·N/A·NCT01888003·51 enrolled

Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Anemia

Unknown status·—·Phase 4·NCT05921968·100 enrolled

Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

Completed·—·Phase 4·NCT06911034·60 enrolled

Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

Completed·FFederal University of São Paulo·Phase 3·NCT01857011·56 enrolled

Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia

Terminated·—·Phase 2·NCT01309659·19 enrolled

Chronic Kidney Disease8 trials

Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

Unknown status·UUniversity Hospital Muenster·Phase 4·NCT00204256·50 enrolled

Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

Withdrawn·AAnemia Working Group Romania·Phase 3·NCT00384657

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Completed·PPharmacosmos A/S·Phase 3·NCT02940860·1,538 enrolled

Show 5 more trials

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Recruiting·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT03619850·129 enrolled

Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients

Recruiting·SSindh Institute of Urology and Transplantation·N/A·NCT06994065·128 enrolled

Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients

Completed·—·Phase 4·NCT06556134·27 enrolled

A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

Completed·AAMAG Pharmaceuticals, Inc.·Phase 2·NCT01052779·162 enrolled

Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

Withdrawn·AAmerican Regent, Inc.·Phase 4·NCT01151592

Iron deficiency anemia7 trials

A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

Completed·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT01114204·605 enrolled

Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy

Available·—··NCT05151679

A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Recruiting·AAMAG Pharmaceuticals, Inc.·Phase 3·NCT03893045·75 enrolled

Show 4 more trials

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Completed·PPharmacosmos A/S·Phase 3·NCT02940886·1,512 enrolled

Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

Completed·AAmerican Regent, Inc.·Phase 3·NCT00981045·2,561 enrolled

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Completed·OOttawa Hospital Research Institute·Phase 2/3·NCT00318812·55 enrolled

Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Completed·—·Phase 3·NCT03009578·100 enrolled

Iron-deficiency3 trials

To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia

Completed·VVifor (International) Inc.·Phase 3·NCT03591406·371 enrolled

A Trial of Iron Replacement in Patients With Iron Deficiency.

Completed·RRichard Fedorak·Phase 4·NCT01067547·130 enrolled

Iron Deficiency and FGF23 Regulation in CKD and HF

Completed·NNorthwestern University··NCT03106298·77 enrolled

Critically Ill2 trials

Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill

Withdrawn·—·Phase 1·NCT02009943

RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone

Withdrawn·—·Phase 2·NCT02047552

24 more indications

Peritoneal Dialysis2 trials

Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients

Terminated·TThe University of Hong Kong·N/A·NCT03610230·16 enrolled

Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Completed·AAmerican Regent, Inc.·Phase 2·NCT00239616·10 enrolled

Intravenous2 trials

Trial Comparing the Safety of Two Different Intravenous Iron Formulations

Suspended·LLondon Health Sciences Centre·Phase 4·NCT00593619·200 enrolled

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

Completed·PPharmacosmos A/S·Phase 3·NCT02130063·511 enrolled

Altitude2 trials

Study of the Effects of Iron Levels on the Lungs at High Altitude

Completed·UUniversity of Oxford·N/A·NCT00952302·33 enrolled

Colorado-Oregon Altitude Study

Completed·UUniversity of Oregon·Phase 4·NCT05734716·121 enrolled

Pregnancy2 trials

Intravenous Treatment of Anemia in Pregnancy

Completed·UUniversity of Zurich·Phase 4·NCT03317210·50 enrolled

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Recruiting·SSaskatchewan Health Authority - Regina Area·Phase 3·NCT05251493·280 enrolled

Hypoxia1 trial

Effects of Iron on Exercise Capacity During Hypoxia

Completed·UUniversity of Oxford·Phase 1·NCT01265108·12 enrolled

Blood Pressure1 trial

Study of the Effects of Iron on Lung Blood Pressure at High Altitude

Withdrawn·UUniversity of Oxford·Phase 2·NCT00960921

Anaemia1 trial

FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

Completed·VVifor Pharma·Phase 3·NCT00810030·484 enrolled

Fatigue1 trial

Iron Therpay and Fatigue in Women of Reprodcutive Age

Completed·—·N/A·NCT06596161·194 enrolled

Dialysis Patients1 trial

Changes in Iron Markers Following Iron Loading in Hemodialysis Patients

Completed·PPapageorgiou General Hospital·Phase 4·NCT00308490·160 enrolled

Hemodialysis1 trial

Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

Completed·AAMAG Pharmaceuticals, Inc.·Phase 4·NCT01227616·296 enrolled

Infusion1 trial

The Safety of a High-Dose, Rapid Infusion of Iron Sucrose

Withdrawn·TThe Guthrie Clinic·Phase 2·NCT02977611

Treatment1 trial

Treatment Response in Dialysis Anaemia

Completed·IImperial College Healthcare NHS Trust·Phase 4·NCT02707757·197 enrolled

MPA1 trial

Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer

Completed· Pfizer logo

Pfizer·Phase 1·NCT00719459·60 enrolled

Maintenance Therapy1 trial

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

Completed·PPharmacosmos A/S·Phase 3·NCT01222884·351 enrolled

Trial1 trial

Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining

Completed·RRuijin Hospital·N/A·NCT03516500·20 enrolled

Arthroplasty1 trial

Intravenous Iron Sucrose in Arthroplasty

Unknown status·KKonkuk University Medical Center·Phase 4·NCT02544828·76 enrolled

Hemoglobin1 trial

Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients

Completed·MMuhammad Aamir Latif·N/A·NCT07115121·40 enrolled

Adult Subject1 trial

Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects

Completed·BBaxter Healthcare Corporation·Phase 1·NCT04155814·196 enrolled

Pediatric1 trial

IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD

Withdrawn·WWayne State University·Phase 2·NCT01438372

Hip Fracture1 trial

Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

Unknown status·HHospital Clinic of Barcelona·Phase 4·NCT01084122·360 enrolled

Endotoxemia1 trial

Effects of Iron Loading and Iron Chelation Therapy on Innate Immunity During Human Endotoxemia

Completed·RRadboud University Medical Center·N/A·NCT01349699·30 enrolled

Mortality1 trial

Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.

Completed·—·Phase 4·NCT02392910·40 enrolled

Kidney Disease1 trial

Iron Sucrose in Stage 3/4 Kidney Disease

Completed·MMelbourne Health·Phase 3·NCT00202345·120 enrolled

Unspecified1 trial

Iron Administration Via Colonic TET Combined With WMT for ID

Not yet recruiting·TThe Second Hospital of Nanjing Medical University·Phase 2·NCT06487299·60 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 20, 2005

VENOFER

NDA NDA021135

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Iron Sucrose. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Venofer drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Iron Sucrose compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Iron Sucrose. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021135). U.S. Food & Drug Administration.
[6]
SEC EDGAR — American Regent, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAmerican Regent, Inc.

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