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Oral iron tablets
Oral iron tablets is a Iron supplement Small molecule drug developed by NICHD Global Network for Women's and Children's Health. It is currently in Phase 3 development for Iron deficiency anemia in pregnant women, Iron deficiency anemia in children. Also known as: Ferrous Sulfate.
Oral iron tablets replenish depleted iron stores and restore hemoglobin synthesis to treat iron deficiency anemia.
Oral iron tablets replenish depleted iron stores and restore hemoglobin synthesis to treat iron deficiency anemia. Used for Iron deficiency anemia in pregnant women, Iron deficiency anemia in children.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Oral iron tablets |
|---|---|
| Also known as | Ferrous Sulfate |
| Sponsor | NICHD Global Network for Women's and Children's Health |
| Drug class | Iron supplement |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Iron is an essential mineral required for hemoglobin production in red blood cells. Oral iron supplementation provides bioavailable iron that is absorbed in the gastrointestinal tract, allowing the body to synthesize adequate hemoglobin and restore oxygen-carrying capacity of blood. This is particularly important in pregnant women and children where iron deficiency anemia can impair development and health outcomes.
Approved indications
- Iron deficiency anemia in pregnant women
- Iron deficiency anemia in children
Common side effects
- Gastrointestinal upset (nausea, abdominal discomfort)
- Constipation
- Dark stools
- Diarrhea
- Metallic taste
Key clinical trials
- Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients. (PHASE1)
- Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study (PHASE3)
- Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial (PHASE3)
- Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia (NA)
- Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA) (NA)
- Effects of Iron Supplements on the Pharmacokinetics of MT-6548 (PHASE3)
- Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis (PHASE2, PHASE3)
- Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral iron tablets CI brief — competitive landscape report
- Oral iron tablets updates RSS · CI watch RSS
- NICHD Global Network for Women's and Children's Health portfolio CI
Frequently asked questions about Oral iron tablets
What is Oral iron tablets?
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Related
- Drug class: All Iron supplement drugs
- Manufacturer: NICHD Global Network for Women's and Children's Health — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Iron deficiency anemia in pregnant women
- Indication: Drugs for Iron deficiency anemia in children
- Also known as: Ferrous Sulfate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing