Delving into the Latest Updates on Herbiron with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

贺必容

Target-

Mechanism-

Therapeutic Areas

Endocrinology and Metabolic DiseaseHemic and Lymphatic DiseasesNervous System Diseases

Active Indication

Anemia, Iron-DeficiencyPrimary dysmenorrhea

Inactive Indication-

Originator Organization

Microbio Co., Ltd.

Active Organization

Microbio Co., Ltd.

Microbio (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

TW (30 Dec 2013),

Anemia, Iron-Deficiency

Regulation-

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BACKGROUNDAbout 468 million non-pregnant women are estimated to suffer from iron-deficiency anemia (IDA) worldwide. The highest prevalence of IDA occurs in the Taiwanese population.OBJECTIVETo evaluate the effectiveness of Herbiron to increase iron absorption in women with IDA.DESIGNPhase III double-blind, randomized, active-controlled, and parallel comparative study enrolled 124 patients with IDA and consisted of a 2-week run-in period, randomization, 12 weeks of supplementation, and 4 weeks of follow-up. The treatment group received Herbiron drink 50 mL p.o., b.i.d., before meals (daily iron intake: 21 mg/day) plus placebo tablets. The control group received a ferrous sulfate tablet, t.i.d., plus placebo 50-mL drink before meals (daily iron intake: 195 mg/day).RESULTSBoth treatments significantly improved hemoglobin and all secondary efficacy endpoints. Most IDA patients treated with Herbiron or ferrous sulfate finished the study in the normal range. Ferrous sulfate treatment induced a rapid rate of hemoglobin synthesis, which plateaued by week 8, whereas Herbiron treatment increased the rate of hemoglobin synthesis more slowly, likely due to its nine-fold lower iron content. Gastrointestinal adverse events (diarrhea, abdominal pain, dyspepsia, and nausea) but not infectious adverse events were significantly more common in the ferrous sulfate group (n=11, 18.3%) than those in the Herbiron group (n=1, 1.6%) (p=0.004).CONCLUSIONTwelve weeks of Herbiron treatment delivering 21mg of iron or ferrous sulfate treatment delivering 195 mg of iron induced normal hemoglobin levels in 62 or 91% of non-pregnant women with IDA in Taiwan, respectively, suggesting dose-dependent and bioavailability effects.

100 Deals associated with Herbiron

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