Last reviewed 2026-05-14 · How we verify

Ferrous sulfate higher concentration

Universidade Federal Fluminense · Phase 2 active Small molecule

Ferrous sulfate higher concentration is a Iron supplement Small molecule drug developed by Universidade Federal Fluminense. It is currently in Phase 2 development for Iron deficiency anemia, Iron supplementation in pregnancy or chronic disease.

Ferrous sulfate at higher concentration provides supplemental iron to treat or prevent iron deficiency by increasing circulating iron available for hemoglobin synthesis.

Ferrous sulfate at higher concentration provides supplemental iron to treat or prevent iron deficiency by increasing circulating iron available for hemoglobin synthesis. Used for Iron deficiency anemia, Iron supplementation in pregnancy or chronic disease.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Ferrous sulfate higher concentration
Sponsor	Universidade Federal Fluminense
Drug class	Iron supplement
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Ferrous sulfate is an iron salt that delivers bioavailable ferrous (Fe2+) iron for absorption in the gastrointestinal tract. At higher concentrations, it increases the amount of iron available for incorporation into hemoglobin and other iron-dependent proteins, correcting iron deficiency anemia. The higher concentration formulation may improve efficacy or reduce dosing frequency compared to standard formulations.

Approved indications

Iron deficiency anemia
Iron supplementation in pregnancy or chronic disease

Common side effects

Gastrointestinal upset (nausea, constipation, abdominal discomfort)
Dark stools
Epigastric pain
Diarrhea

Key clinical trials

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:

Ferrous sulfate higher concentration CI brief — competitive landscape report
Ferrous sulfate higher concentration updates RSS · CI watch RSS
Universidade Federal Fluminense portfolio CI

Frequently asked questions about Ferrous sulfate higher concentration

What is Ferrous sulfate higher concentration?

Ferrous sulfate higher concentration is a Iron supplement drug developed by Universidade Federal Fluminense, indicated for Iron deficiency anemia, Iron supplementation in pregnancy or chronic disease.

How does Ferrous sulfate higher concentration work?

Ferrous sulfate at higher concentration provides supplemental iron to treat or prevent iron deficiency by increasing circulating iron available for hemoglobin synthesis.

What is Ferrous sulfate higher concentration used for?

Ferrous sulfate higher concentration is indicated for Iron deficiency anemia, Iron supplementation in pregnancy or chronic disease.

Who makes Ferrous sulfate higher concentration?

Ferrous sulfate higher concentration is developed by Universidade Federal Fluminense (see full Universidade Federal Fluminense pipeline at /company/universidade-federal-fluminense).

What drug class is Ferrous sulfate higher concentration in?

Ferrous sulfate higher concentration belongs to the Iron supplement class. See all Iron supplement drugs at /class/iron-supplement.

What development phase is Ferrous sulfate higher concentration in?

Ferrous sulfate higher concentration is in Phase 2.

What are the side effects of Ferrous sulfate higher concentration?

Common side effects of Ferrous sulfate higher concentration include Gastrointestinal upset (nausea, constipation, abdominal discomfort), Dark stools, Epigastric pain, Diarrhea.

Drug class: All Iron supplement drugs
Manufacturer: Universidade Federal Fluminense — full pipeline
Therapeutic area: All drugs in Hematology
Indication: Drugs for Iron deficiency anemia
Indication: Drugs for Iron supplementation in pregnancy or chronic disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing