Ferrous Sulfate, Ferric Maltol
Anemia, Iron-Deficiency
Phase III
Completed
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
Oct 27, 2021
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Ferric Maltol Capsule, Ferric Maltol Suspension
Anemia, Iron Deficiency
Phase I
Completed
Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
Oct 22, 2020
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Ferric Maltol
Iron Deficiency, Anaemia In Children, Iron-Deficiency
Phase I
Completed
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
May 23, 2017
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Ferric Maltol
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Phase III
Completed
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
Aug 30, 2016
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Ferric Maltol, Ferric Carboxy Maltose
Crohn's Disease, Inflammatory Bowel Disease, Anemia, Iron-Deficiency
Phase III
Completed
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
Feb 09, 2016
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St10
Crohn's Disease, Iron Deficiency Anaemia, Inflammatory Bowel Disease
Phase III
Completed
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)
May 10, 2011
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St10-021
Ulcerative Colitis, Iron Deficiency Anaemia, Inflammatory Bowel Disease
Phase III
Completed
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
Apr 19, 2011
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Shield Therapeutics PLC (1JS) have in its pipeline
1JS is currently developing the following drugs: Ferrous Sulfate, Ferric Maltol, Ferric Maltol Capsule, Ferric Maltol Suspension, Ferric Maltol. These drug candidates are in various stages of clinical development as the company works toward FDA approval.