TheraRadar
Data updated: Jul 17, 2026

FERRIC CARBOXYMALTOSE · Viatris

Generic · see INJECTAFER
Approved 2013-07-25

FERRIC CARBOXYMALTOSE is FDA-approved to treat 4 conditions (same as INJECTAFER).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-07-25
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Viatris
Active Ingredient: FERRIC CARBOXYMALTOSE

FERRIC CARBOXYMALTOSE Approval History

Original
New Indication
New Form
Label Update
3 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
Update

What FERRIC CARBOXYMALTOSE Treats

4 indications

FERRIC CARBOXYMALTOSE is approved for 4 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as INJECTAFER (same active ingredient).

Source: FDA Label

Viatris's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

PRETOMANID
2019
4 designations
YUPELRI
2018
REVEFENACIN
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Clinical Trial Registry

51 trials
Trial Sponsor ID Phase Status Title
NCT03817957 IDA-II TMP0916_03 Ph 3 completed Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency
NCT02632760 ITACS 605/15 Ph 4 completed Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
NCT07053475 IRONICA 24-11-18-Mufa-OralvsIV-Iron AR2059 Ph 4 recruiting IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
NCT03833336 PREFER-HF PREFER-HF 2016-003604-31 Ph 3 completed Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)
NCT04625530 2020-01194; sp20Amstad Ph 3 withdrawn Perioperative Management in Gynaecological Carcinoma Surgery
NCT06080893 Istanbul Faculty of Medicine Ph 4 completed The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
NCT03680456 POREIIL TPL107 Ph 4 completed Postoperative Replacement of Intraoperative Iron Losses
NCT05744219 IRIS IRIS Ph 3 recruiting Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
NCT04087993 IDA-I TMP0916_02 Ph 3 withdrawn Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients
NCT03769441 EFFECT-KTx 201800450 Ph 3 completed Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation
NCT03037931 HEART-FID results posted 1VIT15043 Ph 3 completed Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
NCT05358509 RAPIDIRON 1811-03347 Ph 4 completed Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial
NCT03991000 iCHF-2 iCHF-2 Ph 3 terminated Iron in Patients With Cardiovascular Disease
NCT04976179 IVON PACTR202012843695208 ISRCTN63484804, Investment ID INV-017271 Ph 3 completed Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)
NCT03218384 results posted 17-00444 Ph 2 terminated Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
NCT04968379 1VIT19046 Ph 2 withdrawn Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
NCT03632525 PID12800 Ph 4 completed Intravenous Iron in Adults With Cystic Fibrosis
NCT05477498 IRON-HFpEF 2018-02280 Ph 4 withdrawn Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction
NCT03523117 results posted 1VIT17044 Ph 3 completed Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
NCT01100879 AOC-MM FER-AOC-MM Ph 4 terminated Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy
NCT04269707 results posted 1VIT18045 Ph 3 completed Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
NCT03759964 FCAACS CEHDF 1050 Ph 4 completed Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery
NCT03380520 IRON-CRT IRON-CRT Ph 4 completed Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
NCT02937454 Affirm-AHF results posted FER-CARS-06 2016-001467-36 Ph 4 completed Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
NCT03591406 results posted VIT-IRON-2011-004 Ph 3 completed To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
NCT03466983 P-Monofer-IBD-03 Ph 4 completed 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
NCT01513369 CLEVER CLEVER-2011 2011-005224-18 Ph 3 completed Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
NCT02905539 HOMe_aFers_1 P-0101 2015-004808-36, U1111-1176-4563 Ph 4 completed A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
NCT02949947 results posted 2015-0588 NCI-2016-01925 Ph 2 terminated Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
NCT03191201 DIAFER 2016-01449 Ph 4 terminated A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
NCT03238911 results posted P-Monofer-IDA-04 Ph 3 completed Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT03237065 results posted P-Monofer-IDA-05 Ph 3 completed Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT04168346 IRONSTOMACH HUS/333/2019 Ph 4 not yet recruiting Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
NCT01692418 PREVENTT 12/0246 2012-002786-35, 10/104/06 Ph 3 completed Preoperative Intravenous Iron to Treat Anaemia in Major Surgery
NCT03399084 1637 FCM_1 Ph 1 completed A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
NCT01978028 Vifor-HF Ph 4 terminated Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
NCT00704353 results posted 1VIT08021 Ph 3 completed Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
NCT00704028 results posted 1VIT08020 Ph 3 completed Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
NCT02009943 COMIRB 13-3151 Ph 1 withdrawn Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill
NCT03079518 Iron Turtle 16-047 Ph 2 completed Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency
NCT02125344 GBG 84 Ph 3 completed 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)
NCT01922479 PRACTICEASIAHF 2013/00265 IMU/BFA/2012/12 Ph 4 completed Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
NCT01701310 IVICA 11GS005 2011-002185-21, PB-PG-0110-21041 Ph 4 completed IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
NCT01787526 IronWoMan 1.0 2013-000327-14 Ph 3 completed Intravenous High Dose Iron in Blood Donors
NCT01837082 iCHF iCHF_D.3874 2012-001134-33 Ph 3 terminated Iron in Congestive Heart Failure
NCT01913808 FEV-POST/ESP10 2010-023038-22 Ph 4 completed Comparing Intravenous and Oral Iron in Postoperative Anemia
NCT01154491 PAHFRAC PAHFRAC-01 2009-015865-30 Ph 3 completed Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period
NCT01245777 ITiRiP-1 Ph 4 completed Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy
NCT01101399 FID-CHEMO FER-FID-CHEMO Ph 3 completed Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy
NCT00810030 FER-IBD-COR FER-IBD-07-COR Ph 3 completed FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

Showing 50 of 51 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FERRIC CARBOXYMALTOSE FDA Label Details

Indications & Usage

FERRIC CARBOXYMALTOSE is FDA-approved to treat 4 conditions — same approved indications as INJECTAFER.

Looking for the branded version?

INJECTAFER

Full clinical data, patents, trials, and competitive landscape for ferric carboxymaltose.

See INJECTAFER

Data Sources

FDA Approval: ANDA217076 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.