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Injectafer

(Ferric Carboxymaltose)

ApprovedSmall molecule

AAmerican Regent, Inc.

Ferric carboxymaltose is used to treat iron deficiency anemia, a condition where your body doesn't have enough iron to make healthy red blood cells, which can cause fatigue and weakness.[2] Injectafer is currently approved and in use across 28 indications[4].[1]

Injectafer is one of 696 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

28

Indications

107

Total Trials

10

Active Trials

695

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

9

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Hip FractureApproved

Acute Coronary SyndromeActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Restless Legs SyndromeApproved

Colon CarcinomaActive, not recruiting

Kidney TransplantActive, not recruiting

Pulmonary HypertensionActive, not recruiting

Malignant Colon NeoplasmActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

Hip FractureApproved

Approved

Acute Coronary SyndromeApproved

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Restless Legs SyndromeApproved

Approved

Colon CarcinomaPreclinical

Active, not recruiting

Kidney TransplantPhase 3

Active, not recruiting

Pulmonary HypertensionApproved

Active, not recruiting

Malignant Colon NeoplasmPreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 2

Active, not recruiting

Showing 10 of 27 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Injectafer

AAmerican Regent, Inc.

Recentin

NNational Cancer Institute (NCI)

Spravato

Avastin

Nubain

AAultman Health Foundation

Feraheme

AAzurity Pharmaceuticals

QS21

MMemorial Sloan Kettering Cancer Center

Beta Blocker

WWeill Medical College of Cornell University

Perflutren Lipid Microcpheres

TThomas Jefferson University

Lipegfilgrastim

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Gastric Cancer

NCT04168346

Post-ApprovalNot yet recruiting

Iron Deficiency Anemia

NCT07414199

Q1 2027

Post-ApprovalRecruiting

Heart Failure

NCT07053475

Q1 2028

Phase 3Recruiting

Blood Loss

NCT05744219

Q2 2028

Post-ApprovalRecruiting

Acute Coronary Syndrome

NCT07476859

Clinical

Trials by Indication[1]

Iron deficiency anemia13 trials

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Completed·AAmerican Regent, Inc.·Phase 3·NCT04269707·7 enrolled

Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

Completed·AAmerican Regent, Inc.·Phase 3·NCT00704028·161 enrolled

Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Completed·AAmerican Regent, Inc.·Phase 3·NCT00548860·2,018 enrolled

Show 10 more trials

A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

Completed· Novartis logo

Novartis·Phase 1·NCT03399084·71 enrolled

Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)

Completed·UUniversity of Lagos, Nigeria·Phase 3·NCT04976179·1,056 enrolled

Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

Completed·AAmerican Regent, Inc.·Phase 3·NCT00704353·735 enrolled

IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania

Unknown status·IIfakara Health Institute·Phase 3·NCT02541708·230 enrolled

Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia

Withdrawn·AAmerican Regent, Inc.·Phase 2·NCT04968379

Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

Completed·AAmerican Regent, Inc.·Phase 3·NCT00982007·997 enrolled

The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department

Not yet recruiting·—·Phase 4·NCT07414199·150 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

Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

Completed·AAmerican Regent, Inc.·Phase 3·NCT00703937·708 enrolled

Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

Completed·AAmerican Regent, Inc.·Phase 2·NCT01290315·49 enrolled

Heart Failure12 trials

Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency

Terminated·NNYU Langone Health·Phase 2·NCT03218384·20 enrolled

Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose

Terminated·UUniversity of Zurich·Phase 4·NCT01978028·20 enrolled

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

Completed·AAmerican Regent, Inc.·Phase 3·NCT03037931·3,065 enrolled

Show 9 more trials

Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction

Withdrawn·CCantonal Hosptal, Baselland·Phase 4·NCT05477498

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency

Completed·VVifor (International) Inc.·Phase 4·NCT02937454·1,132 enrolled

Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency

Completed·RRWTH Aachen University·Phase 2·NCT03079518·23 enrolled

Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure

Unknown status·HHospital Moinhos de Vento·Phase 4·NCT03871699·20 enrolled

Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)

Completed·IInstitut de Recerca Biomèdica de Lleida·Phase 3·NCT03833336·72 enrolled

IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches

Recruiting·SSyed Hamza Mufarrih·Phase 4·NCT07053475·250 enrolled

Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction

Unknown status·—··NCT04974021·106 enrolled

Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure

Completed·NNational University Hospital, Singapore·Phase 4·NCT01922479·50 enrolled

Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

Completed·NNYU Langone Health·Phase 1·NCT02737995·8 enrolled

Anemia9 trials

Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery

Completed·SSt Joseph University, Beirut, Lebanon·Phase 4·NCT03759964·194 enrolled

Comparing Intravenous and Oral Iron in Postoperative Anemia

Completed·PParc de Salut Mar·Phase 4·NCT01913808·122 enrolled

The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly

Recruiting·XXuanwu Hospital, Beijing·N/A·NCT07057973·100 enrolled

Show 6 more trials

Hypoferritinemia Without Anemia Among Reproductive Age Females

Active, not recruiting·AAkram Medical Complex·N/A·NCT06437080·1,331 enrolled

Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia

Terminated·NNorwegian University of Science and Technology·Phase 2/3·NCT00929409·30 enrolled

Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

Completed·HHospital Universitario Infanta Cristina··NCT06948864·152 enrolled

Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)

Unknown status·—·Phase 4·NCT04083755·240 enrolled

Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

Completed·KKing Hussein Cancer Center·N/A·NCT04246021·84 enrolled

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Completed·AAmerican Regent, Inc.·Phase 3·NCT00395993·456 enrolled

Iron-deficiency6 trials

Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients

Withdrawn·—·Phase 3·NCT04087993

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

Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Unknown status·—·Phase 4·NCT04786769·2,500 enrolled

Show 3 more trials

Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency

Completed·PProf. Dr. Frank Behrens·Phase 3·NCT03817957·187 enrolled

Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

Completed·VVifor Pharma·Phase 3·NCT01101399·19 enrolled

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia

Completed·SSichuan Huiyu Pharmaceutical Co., Ltd·Phase 1·NCT06080555·84 enrolled

Chronic Kidney Disease5 trials

Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

Completed·AAmerican Regent, Inc.·Phase 3·NCT00548691·513 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

Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Completed·AAmerican Regent, Inc.·Phase 3·NCT00317226·145 enrolled

Show 2 more trials

Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)

Completed·—·Phase 4·NCT02232906·30 enrolled

VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Completed·AAmerican Regent, Inc.·Phase 3·NCT00317239·255 enrolled

46 more indications

Intravenous4 trials

Intravenous Iron Pre-treatment in Prognathic Surgery

Unknown status·KKonkuk University Medical Center·N/A·NCT02800746·48 enrolled

Intravenous High Dose Iron in Blood Donors

Completed·MMedical University of Graz·Phase 3·NCT01787526·176 enrolled

Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

Completed·HHasselt University·Phase 4·NCT03380520·75 enrolled

Show 1 more trial

Intravenous Iron: Measuring Response in Anemic Surgical Patients

Completed·NNottingham University Hospitals NHS Trust·Phase 4·NCT02057471·20 enrolled

Hypophosphatemia3 trials

Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

Completed·PPharmacosmos A/S·Phase 3·NCT03238911·123 enrolled

Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

Completed·PPharmacosmos A/S·Phase 3·NCT03237065·122 enrolled

Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

Completed·AAmerican Regent, Inc.·Phase 2·NCT01307007·69 enrolled

Inflammatory Bowel Disease3 trials

Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial

Unknown status·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 3·NCT04587141·300 enrolled

A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

Completed·PPharmacosmos A/S·Phase 4·NCT03466983·97 enrolled

Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue

Unknown status·IIstituto Clinico Humanitas·Phase 2·NCT02517151·36 enrolled

Restless Legs Syndrome3 trials

Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

Completed·UUniversity of Zurich·Phase 4·NCT01245777·15 enrolled

Intravenous Iron Metabolism in Restless Legs Syndrome

Completed·AAmerican Regent, Inc.·Phase 2·NCT00685815·12 enrolled

Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

Completed·AAmerican Regent, Inc.·Phase 2·NCT01382901·45 enrolled

CAR3 trials

Effect of Postoperative Ferric Carboxymaltose

Unknown status·TThe Catholic University of Korea·Phase 4·NCT03561480·80 enrolled

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants

Completed·SSichuan Huiyu Pharmaceutical Co., Ltd·Phase 1·NCT06895993·84 enrolled

Iron Status and Cardiopulmonary Physiology

Completed·RRoyal Centre for Defence Medicine·N/A·NCT03707249·18 enrolled

Intraoperative2 trials

Postoperative Replacement of Intraoperative Iron Losses

Completed·KKepler University Hospital·Phase 4·NCT03680456·134 enrolled

Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Unknown status·KKonkuk University Medical Center·Phase 4·NCT04035902·46 enrolled

Cardiac Surgery2 trials

Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

Completed·BBayside Health·Phase 4·NCT02632760·955 enrolled

Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery

Unknown status·TTurku University Hospital·Phase 4·NCT03574311·210 enrolled

Total Knee Arthroplasty2 trials

Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty

Unknown status·TThe Catholic University of Korea·Phase 4·NCT03561506·80 enrolled

Does Intraoperative Intravenous Iron Enhance Postoperative Oxygenation Profile in Total Knee Arthroplasty Surgery?

Completed·KKonkuk University Medical Center·Phase 4·NCT02544464·76 enrolled

Hip Fracture2 trials

The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures

Completed·IIstanbul University·Phase 4·NCT06080893·209 enrolled

Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period

Completed·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 3·NCT01154491·303 enrolled

Hemoglobin2 trials

Ferric Carboxymaltose Methemoglobinemia Study

Completed·OOrdu University··NCT06958822·977 enrolled

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

Anaemia1 trial

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

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

Blood Loss1 trial

Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial

Recruiting·JJon Unosson·Phase 3·NCT05744219·338 enrolled

Kidney Transplant1 trial

Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

Completed·UUniversity Medical Center Groningen·Phase 3·NCT03769441·148 enrolled

Cardiac Surgical Patients1 trial

Patient Blood Management In CARdiac sUrgical patientS

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT04744181·479 enrolled

Complication1 trial

Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial

Unknown status·SSingapore General Hospital·Phase 4·NCT03295851·60 enrolled

Critically Ill1 trial

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

Withdrawn·—·Phase 1·NCT02009943

Colorectal Cancer1 trial

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

Completed·NNottingham University Hospitals NHS Trust·Phase 4·NCT01701310·116 enrolled

Type 2 Diabetes Mellitus1 trial

Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency

Completed·GGWT-TUD GmbH·Phase 3·NCT01513369·152 enrolled

Homeostasis1 trial

A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.

Terminated·PProf Gérard WAEBER·Phase 4·NCT03191201·32 enrolled

Hemodialysis1 trial

Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?

Unknown status·—·Phase 4·NCT04627181·100 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

Unknown status·RRoyal Brompton & Harefield NHS Foundation Trust·Phase 2·NCT03050424·40 enrolled

Cystic Fibrosis1 trial

Intravenous Iron in Adults With Cystic Fibrosis

Completed·UUniversity of Oxford·Phase 4·NCT03632525·20 enrolled

Gastric Cancer1 trial

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Not yet recruiting·HHelsinki University Central Hospital·Phase 4·NCT04168346·202 enrolled

Pediatric Patients1 trial

Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

Completed·AAmerican Regent, Inc.·Phase 3·NCT03523117·79 enrolled

Multiple Myeloma1 trial

Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

Terminated·VVifor Pharma·Phase 4·NCT01100879·3 enrolled

Carcinoma1 trial

Perioperative Management in Gynaecological Carcinoma Surgery

Withdrawn·UUniversity Hospital, Basel, Switzerland·Phase 3·NCT04625530

Neuroimaging1 trial

Neuroimaging Ancillary Study

Completed·TThomas Jefferson University··NCT05545527·184 enrolled

Colon Cancer1 trial

Preoperative i.v. Iron Substitution in Patients With Colon Cancer

Unknown status·HHelsinki University Central Hospital·N/A·NCT04653181·514 enrolled

Breast Cancer1 trial

A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)

Completed·GGBG Forschungs GmbH·Phase 3·NCT02125344·961 enrolled

Gastrointestinal Stromal Tumor1 trial

Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02949947·3 enrolled

Congestive Heart Failure1 trial

Iron in Congestive Heart Failure

Terminated·UUniversity of Ulm·Phase 3·NCT01837082·18 enrolled

Metabolism1 trial

Iron Status and Human Metabolism

Completed·UUniversity of Oxford·N/A·NCT02308449·29 enrolled

Pregnancy1 trial

Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial

Completed·TThomas Jefferson University·Phase 4·NCT05358509·4,368 enrolled

Efficacy1 trial

An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function

Completed·—·N/A·NCT05309499·298 enrolled

Major Surgery1 trial

Preoperative Intravenous Iron to Treat Anaemia in Major Surgery

Completed·UUniversity College, London·Phase 3·NCT01692418·487 enrolled

MPA1 trial

A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer

Completed·UUniversität des Saarlandes·Phase 4·NCT02905539·26 enrolled

Trial1 trial

RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study

Unknown status·TThomas Jefferson University··NCT05504863·538 enrolled

Cardiovascular Disease1 trial

Iron in Patients With Cardiovascular Disease

Terminated·DDr. med. Mahir Karakas·Phase 3·NCT03991000·8 enrolled

Preoperative1 trial

Management of Preoperative Anaemia in Surgical Oncology

Unknown status·AAzienda Ospedaliera Universitaria Integrata Verona·Phase 4·NCT05505006·500 enrolled

Pulmonary Hypertension1 trial

The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension

Recruiting·ZZiekenhuis Oost-Limburg·Phase 4·NCT07359599·306 enrolled

Infertility1 trial

Iron Deficiency as an Ignored Cause of Infertility

Unknown status·DDextra Fertility Clinic·Phase 4·NCT04510870·62 enrolled

Acute Coronary Syndrome1 trial

Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome

Recruiting·FFundación para la Investigación del Hospital Clínico de Valencia·Phase 4·NCT07476859·538 enrolled

Pediatric1 trial

A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

Completed·AAmerican Regent, Inc.·Phase 2·NCT02410213·35 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

Completed·AAmerican Regent, Inc.·Phase 3·NCT00354484·291 enrolled

Infusion1 trial

Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

Recruiting·EErasmus Medical Center·Phase 4·NCT07370688·402 enrolled

Treatment1 trial

Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia

Unknown status·—·Phase 4·NCT02243735·198 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 5, 2014

AURYXIA

NDA NDA205874

Apr 28, 2021

INJECTAFER

NDA NDA203565

Sources

References

[1]
ClinicalTrials.gov — 107 trial records for Ferric Carboxymaltose. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Injectafer drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ferric Carboxymaltose compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ferric Carboxymaltose. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203565). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Injectafer. U.S. Food & Drug Administration.
[7]
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.

Patent Landscape[6]

Patent Cliff

Jan 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8093423Apr 21, 2026

8895612Jan 8, 2027

11478502Jan 8, 2027

11433091Jan 8, 2027

11364260Jan 8, 2027

4 more patents

7612109Feb 5, 2027

7754702Feb 15, 2028

10300039Jul 21, 2030

9387191Jul 21, 2030

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