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Ferrum Lek, chewable · 1 trial · 1 indication
Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups
| Arm | Type | Description |
|---|---|---|
| Ferrum Lek | EXPERIMENTAL | Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks |
| MALTOFER | ACTIVE_COMPARATOR | Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) | DRUG | Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks |
| MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) | DRUG | Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks |
Inclusion Criteria: 1. The signed and dated written informed consent prior to participation in the study. 2. Men and women aged 18 and older (by the time of screening). 3. Outpatients. 4. Diagnosed iron-deficiency anemia, based on two criteria: 1. hemoglobin level below 110 g/L (in men and wome...
Ferrum Lek, chewable is an oral iron therapy supplied as 100 mg chewable tablets containing iron (III) hydroxide polymaltosate. It is being studied for the treatment of mild and moderate iron-deficiency anaemia in adults. The product is associated with Lek d.d. of Slovenia and is listed as a small molecule hematology asset.
Ferrum Lek, chewable is used for mild and moderate iron-deficiency anaemia. Its clinical program enrolled adults aged 18 years and older with that condition, and the study was conducted in Russia. Iron-deficiency anaemia is the sole indication described for this chewable tablet formulation.
Ferrum Lek, chewable is developed by Novartis AG, which trades under the ticker NVS. The chewable tablet product is associated with Lek d.d. of Slovenia, and the comparator used in its clinical study was MALTOFER from Vifor S.A. of Switzerland.
Ferrum Lek, chewable is in Phase 3 development. It is an investigational product and is not described as approved. One Phase 3 trial has been completed, and no trials are currently listed as active, so the clinical program for this chewable formulation has finished its reported study.
Ferrum Lek, chewable was evaluated in the completed Phase 3 trial NCT03993288, titled a study testing non-inferior efficacy and safety of Ferrum Lek 100 mg chewable tablets versus MALTOFER in subjects with mild and moderate iron deficiency anemia. The trial was randomized, active-controlled, and enrolled 267 participants in Russia.
Ferrum Lek, chewable refers to the Ferrum Lek iron (III) hydroxide polymaltosate 100 mg chewable tablets from Lek d.d., Slovenia. Ferrum Lek is the brand name, and the chewable tablet is the specific oral formulation described here, so searches for either name point to the same product line.