Data updated: May 26, 2026
VENOFER (iron sucrose)
Trial Activity: Declining 5 active trials
Renal
Approved 2000-11-06
Development Insights
AMAG Pharmaceuticals, Inc. conducting 5 trials (17%)
33 indications explored (Broad Platform)
→ anemia (7 trials)
→ iron deficiency anemia (6 trials)
→ iron deficiency (5 trials)
5
Indications
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2000-11-06
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
VENOFER Approval History
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
125 FDA actions from 2000 to 2026 · 4 indication expansions
Jun 2016 SUPPL
Mfg
May 2016 SUPPL
Mfg
Mar 2016 SUPPL
Mfg
May 2015 SUPPL
Mfg
Jun 2014 SUPPL
Mfg
Dec 2002 SUPPL
Mfg
Jan 2002 SUPPL
Mfg
Feb 2001 SUPPL
Label
What VENOFER Treats
5 FDA approvalsOriginally approved for its first indication in 2000 . Covers 5 distinct patient populations.
- Other (5)
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Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03893045 | AMAG-FER-IDA-352 | Ph 3 | recruiting | A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects |
| NCT03619850 | AMAG-FER-CKD-354 | Ph 3 | recruiting | 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) |
| NCT05251493 | HC6-024-c260086 SHA REB-21-64 | Ph 3 | recruiting | Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy |
| NCT05800600 Iron-RANC | 22-1053 HM-213 | Ph 2 | recruiting | Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy |
| NCT06487299 | TET- RCT-Fe | Ph 2 | not yet recruiting | Iron Administration Via Colonic TET Combined With WMT for ID |
| NCT01052779 FIRST results posted | FER-CKD-201 2009-015630-30 | Ph 2 | completed | A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease |
| NCT01227616 results posted | AMAG-FER-CKD-401 | Ph 4 | completed | Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis |
| NCT01114204 results posted | AMAG-FER-IDA-302 | Ph 3 | completed | A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia |
| NCT03528564 HOPE-Hb | HOPE-Hb | Ph 2 | terminated | Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia |
| 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 |
| NCT02707757 PRIME results posted | 14HH1987 | Ph 4 | completed | Treatment Response in Dialysis Anaemia |
| NCT02940860 results posted | P-Monofer-CKD-04 | Ph 3 | completed | Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease |
| NCT02940886 results posted | P-Monofer-IDA-03 | Ph 3 | completed | Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) |
| NCT02047552 | 14-0167 | Ph 2 | withdrawn | RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone |
| NCT03093883 | AZAD-BE03 2016-003602-14 | Ph 1 | completed | Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers |
| NCT02009943 | COMIRB 13-3151 | Ph 1 | withdrawn | Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill |
| NCT00384657 | AWG_06_01 | Ph 3 | withdrawn | Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease |
| NCT02977611 | 1611-56 | Ph 2 | withdrawn | The Safety of a High-Dose, Rapid Infusion of Iron Sucrose |
| NCT02390921 BARIFER | PR(AG)275/2014 | Ph 4 | completed | The Use of Liposomated Iron After Bariatric Surgery in Patients That Are Receiving Parentheral Therapy With Iron |
| NCT00719459 | IRON-07-04 | Ph 1 | completed | Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer |
| NCT01309659 results posted | Pro00028687 U01AG034661, PACTTE_01 | Ph 2 | terminated | Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia |
| NCT01222884 results posted | P-Monofer-CKD-03 | Ph 3 | completed | 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 |
| NCT01067547 | UA 2009 TL | Ph 4 | completed | A Trial of Iron Replacement in Patients With Iron Deficiency. |
| NCT00810030 FER-IBD-COR | FER-IBD-07-COR | Ph 3 | completed | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR |
| NCT00593619 | HSREB13767 | Ph 4 | suspended | Trial Comparing the Safety of Two Different Intravenous Iron Formulations |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
VENOFER FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment