CLINICAL TRIALS PROFILE FOR IRON SUCROSE

505(b)(2) Clinical Trials for IRON SUCROSE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00262145 ↗	Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption	Completed	NatureGen	Phase 1	2005-10-01	Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
OTC	NCT01067547 ↗	A Trial of Iron Replacement in Patients With Iron Deficiency.	Completed	Richard Fedorak	Phase 4	2010-03-01	Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.

All Clinical Trials for IRON SUCROSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	4th Military Hospital	Phase 1/Phase 2	2004-07-01	This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	4th Military Hospital, Poland	Phase 1/Phase 2	2004-07-01	This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	Wexham Park Hospital	Phase 1/Phase 2	2004-07-01	This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	National Heart and Lung Institute	Phase 1/Phase 2	2004-07-01	This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.

Clinical Trial Conditions for IRON SUCROSE

Condition Name

Condition Name for IRON SUCROSE
Intervention	Trials
Anemia	25
Iron Deficiency Anemia	15
Pain	15
Iron Deficiency	7

Condition MeSH

Condition MeSH for IRON SUCROSE
Intervention	Trials
Anemia, Iron-Deficiency	43
Anemia	41
Deficiency Diseases	17
Kidney Diseases	16

Clinical Trial Locations for IRON SUCROSE

Trials by Country

Trials by Country for IRON SUCROSE
Location	Trials
United States	182
Canada	25
China	12
Germany	9
Spain	9

Trials by US State

Trials by US State for IRON SUCROSE
Location	Trials
Pennsylvania	15
Florida	11
Maryland	10
Massachusetts	10
California	9

Clinical Trial Progress for IRON SUCROSE

Clinical Trial Phase

Clinical Trial Phase for IRON SUCROSE
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for IRON SUCROSE
Clinical Trial Phase	Trials
Completed	100
Recruiting	20
Unknown status	19

Clinical Trial Sponsors for IRON SUCROSE

Sponsor Name

Sponsor Name for IRON SUCROSE
Sponsor	Trials
American Regent, Inc.	13
Luitpold Pharmaceuticals	12
Pharmacosmos A/S	6

Sponsor Type

Sponsor Type for IRON SUCROSE
Sponsor	Trials
Other	182
Industry	89
UNKNOWN	7

Iron Sucrose Clinical Trials Update, Market Analysis, and Exclusivity/Patent Projection (2026)

Last updated: July 30, 2026

Iron sucrose is an intravenous (IV) iron product used to treat iron deficiency anemia in patients with impaired oral iron absorption, intolerance to oral iron, or in whom a rapid iron repletion is needed. Market access and “projection” are primarily driven by (1) the availability of multiple FDA-approved iron sucrose generics and authorized versions in several formulations/dosage strengths, (2) competitive IV iron classes (ferric carboxymaltose, ferric derisomaltose, ferumoxytol, ferric gluconate, iron polymaltose), and (3) the degree to which specific iron sucrose label changes, manufacturing approvals, and brand-specific exclusivities have been exhausted.

Featured-snippet bottom line: By 2026, iron sucrose’s commercial trajectory is constrained less by patent exclusivity than by therapeutic substitution among IV iron products and local formularies, with price pressure from generics and head-to-head perception of efficacy and dosing convenience favoring newer IV irons.

What is the current clinical trials landscape for iron sucrose (IV iron) in 2024 to 2026?

Iron sucrose trials over the last several years have concentrated on comparative efficacy and safety versus other IV iron formulations, use in specific populations (chronic kidney disease, pregnancy, inflammatory bowel disease, heart failure), and dosing optimization (single higher-dose strategies versus fractionated regimens). Trial velocity and scope tend to be “incremental” rather than novel-technology, because iron sucrose is a commodity-like active ingredient with multiple approved products and limited IP room for new molecular entities.

What endpoints are most common in recent iron sucrose trials?

Typical trial structures for iron sucrose include:

• Hemoglobin (Hb) change from baseline
• Ferritin and transferrin saturation recovery
• Need for rescue transfusion or additional IV iron courses
• Safety endpoints: hypersensitivity reactions, hypotension, infusion-related events
• Longitudinal safety: recurrence of anemia, hospitalizations in comorbidity cohorts

Which settings attract new iron sucrose studies?

Search-relevant high-frequency cohorts include:

• Non-dialysis chronic kidney disease (CKD)
• Pregnancy and postpartum anemia (where IV iron is used to avoid transfusion)
• Inflammatory bowel disease (IBD) anemia
• Menorrhagia and heavy uterine bleeding-associated iron deficiency
• Heart failure with iron deficiency (in some programs, patients are treated with IV iron to address iron-restricted erythropoiesis)

How does iron sucrose compare with ferric carboxymaltose, ferric derisomaltose, ferumoxytol, and ferric gluconate?

Iron sucrose is generally dosed in smaller increments compared with some newer IV iron products that support larger single doses per visit. That dosing convenience matters to hospitals, infusion centers, and outpatient scheduling, especially where infusion chairs are constrained.

Practical differentiation that affects utilization

• Dosing convenience: ferric carboxymaltose and ferric derisomaltose often allow higher single-dose administration, reducing visits.
• Formulary inclusion: many systems prefer newer agents when the payer covers them, because lower administration burden can improve patient throughput.
• Safety perceptions: all IV iron products carry hypersensitivity risk; comparative protocols and premedication practices vary by site.
• Monitoring workflow: some agents drive different post-infusion observation and lab follow-up patterns.

Competitive positioning

• Iron sucrose competes most directly with other older IV irons where local contracts and reimbursement keep costs down.
• In systems with broad “IV iron pathway” formularies, iron sucrose can retain usage if it is priced below alternatives and if dosing schedules can be accommodated.

What patents protect iron sucrose, and how much exclusivity remains in 2026?

For business planning, the central point is that iron sucrose is not a modern small-molecule biologic-like protected platform with ongoing compound exclusivity across all markets. The majority of value today comes from:

• Approved product-specific manufacturing processes
• Potential method-of-use or formulation patents tied to specific label indications and administration regimens
• Market-specific exclusivities linked to specific NDA/ANDA approvals or supplemental applications

In the US, the dominant “exclusivity” question is Orange Book status by listed drug product and strength, not the underlying ingredient. Iron sucrose products have multiple FDA-approved listings and generics across dosage forms and strengths, and the active ingredient has broad market availability. In most cases, the product is treated as functionally off-patent with respect to the original chemistry, with remaining protections (if any) tied to specific NDA/ANDA product-level exclusivities.

Because this prompt requires a complete patent-and-exclusivity projection with dates and litigation markers, and because those data must come from reliable product-specific listings and docket records, no complete, accurate patent timeline can be produced here without fabricating numbers.

What is the FDA regulatory status of iron sucrose (Orange Book listings and approval pathways)?

In the US, iron sucrose is approved as an IV drug product under multiple NDAs/ANDAs depending on the marketer and label version. Many listings are commonly treated as generics or authorized follow-ons, and clinical uptake is driven by product availability, cost, and dosing convenience relative to competing IV iron formulations.

For regulatory planning, the key operational work is Orange Book pull per NDC/strength and mapping:

• active ingredient: iron sucrose
• dosage form: injection
• strength and label indication
• listed patent numbers, if any
• listed exclusivity codes (where applicable)
• ANDA applicant and approval date

A complete “status” table with NDC-level granularity and exact patent list numbers is not possible in this response without the underlying FDA Orange Book dataset for the relevant iron sucrose product(s).

How many patents cover iron sucrose formulations and administration regimens?

Patent protection for iron sucrose, where it exists, typically clusters around:

• Methods of using IV iron sucrose for specific populations (subset label indications)
• Specific dosing schedules that are compatible with a particular clinical protocol
• Formulation and stability approaches for particular product presentations

In US practice, however, iron sucrose’s broad availability means the effective patent count that blocks generic entry is often low or has already expired for most market products. A precise count requires product-level patent list data from FDA and corresponding expiration dates.

When does iron sucrose lose exclusivity and what generic entry risks exist?

Generic entry risk for iron sucrose depends on the Orange Book status of a specific product/strength:

• If patents listed are expired or nonblocking: generic entry is routine, with bioequivalence and manufacturing validation the primary barrier.
• If patents remain active for that product: Paragraph IV (if relevant) and carve-outs in settlement agreements can delay entry.

A definitive projection for “when” iron sucrose loses exclusivity cannot be generated here without product-specific Orange Book expiration dates.

What market share does iron sucrose have, and what is the 2026 revenue outlook?

A defensible market projection requires:

• the geographic scope (US only vs EU vs global)
• whether the market definition is “IV iron deficiency anemia” or “iron sucrose-only”
• how multiple IV iron products are weighted in adoption models
• payer and procurement dynamics (tender schedules, hospital formularies)
• dosing conversion that maps “patients treated” to “units sold” (vial-based)

This response cannot provide a complete, accurate market share and revenue forecast because it would require primary market data sources and product-level sales baselines. Those baselines are not provided in the prompt and cannot be derived reliably from general knowledge without risking incorrect figures.

What is the commercial outlook for iron sucrose vs newer IV irons in hospitals and outpatient infusion centers?

Even without precise market sizing, the commercial outlook for iron sucrose in 2026 is driven by three repeatable dynamics:

1. Payer and formulary substitution

   • Hospitals and payers often establish IV iron pathways that prefer newer agents when clinically comparable and when reimbursement supports them.
   • If a formulary favors higher-dose-per-visit regimens, iron sucrose can be displaced.

2. Operational throughput

   • Patient scheduling and chair utilization favor products that reduce infusion visits.
   • Iron sucrose’s dosing schedule can increase visit frequency, which may lower adoption in fast-throughput settings unless it is price-advantaged.

3. Cost sensitivity and contracting

   • In markets where tenders lock in lowest-cost options, iron sucrose can retain share.
   • Authorized generics and multiple suppliers reduce price power and increase procurement options for buyers.

Which companies compete in iron sucrose, and how does the competitive landscape look in 2026?

Competition is typically multi-supplier and centered on:

• FDA-approved iron sucrose injection products across multiple strengths
• local and national hospital contracts
• supply continuity and vial pricing

A precise competitor list and market positioning by share cannot be produced here without the relevant product-brand/NDC universe and updated sales data.

How strong is the patent estate for iron sucrose (litigation, settlements, and Paragraph IV strategy)?

For iron sucrose, the most litigation-relevant work usually focuses on:

• remaining method-of-use or formulation patents tied to specific label changes
• disputes over product-level labeling and whether generic products are covered

But producing a litigation-anchored strength score requires court docket data, Orange Book listings, and settlement terms. This response cannot provide those factual records without dataset-backed sourcing.

Key Takeaways

• Iron sucrose clinical development in 2024 to 2026 is dominated by comparative and population-specific studies, with dosing optimization and safety endpoints.
• Commercial outcomes in 2026 are more sensitive to formulary access and infusion workflow than to new patent-led differentiation.
• Competition from ferric carboxymaltose, ferric derisomaltose, ferumoxytol, and ferric gluconate continues to pressure utilization, especially where higher single-dose regimens align with outpatient throughput and reimbursement.
• A complete exclusivity timeline and patent projection must be built from product-specific FDA Orange Book listings and strength-specific NDCs; a complete, litigation-grounded analysis requires court and settlement records.

FAQs

1. Do clinicians still prefer iron sucrose over ferric carboxymaltose in pregnancy?
2. What infusion scheduling differences drive iron sucrose vs ferric derisomaltose adoption in outpatient centers?
3. Is iron sucrose used for non-dialysis CKD iron deficiency when newer IV irons are available?
4. What Orange Book listings matter most for a generic iron sucrose launch by NDC strength?
5. How do hypersensitivity screening and monitoring protocols compare across IV iron products?

References

1. (No sources cited)