Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ferrous ascorbate · 1 trial · 1 indication
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
| Arm | Type | Description |
|---|---|---|
| ferrous bisglycinate chelate 1 OD | EXPERIMENTAL | ferrous bisglycinate chelate 1 tablet daily |
| ferrous ascorbate | ACTIVE_COMPARATOR | ferrous ascorbate, 1 tablet daily |
| ferrous bisglycinate chelate 2 OD | EXPERIMENTAL | ferrous bisglycinate chelate 2 tablets daily |
| Name | Type | Description |
|---|---|---|
| ferrous ascorbate | DRUG | 100 mg elemental iron |
| ferrous bisglycinate chelate 1 OD | DIETARY_SUPPLEMENT | 60 mg elemental iron |
| ferrous bisglycinate chelate 2 OD | DIETARY_SUPPLEMENT | 120 mg elemental iron |
Inclusion Criteria Subjects eligible for enrolment to the study must meet all of the following criteria: 1. Signed and dated written informed consent is obtained prior to participation. 2. Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually acti...
Ferrous ascorbate is an investigational small molecule being studied for haematopoiesis, specifically in the context of iron deficiency anaemia. It is being developed by GSK plc (GSK) and is currently in Phase 3 clinical development. The drug is intended to support the production of blood cells.
Ferrous ascorbate is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's efficacy and tolerability in patients with iron deficiency anaemia. GSK is responsible for the drug's development and regulatory pathway.
Ferrous ascorbate is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, NCT01160198, has been completed, and the drug is being evaluated for its efficacy and tolerability in treating iron deficiency anaemia.
Ferrous ascorbate has one completed Phase 3 clinical trial, NCT01160198, titled 'A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.' The trial enrolled 271 female participants aged 18 years and older in India and was active-controlled but not double-blinded.
Ferrous ascorbate is not the same as ferrous bisglycinate chelate. In the clinical trial NCT01160198, ferrous bisglycinate chelate is the investigational drug being compared against ferrous ascorbate, which serves as the active control. They are distinct iron formulations evaluated for their relative efficacy and tolerability in treating iron deficiency anaemia.