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Normosang (HEMIN)

FDA-approved active Small molecule Quality 45/100

Normosang replenishes heme, a crucial component in hemoglobin production, to treat Acute Intermittent Porphyria.

HEMIN (Normosang) is a marketed drug used to treat acute intermittent porphyria by replenishing heme, a critical component in hemoglobin production. Its key strength lies in being a first-in-class therapy that directly addresses the underlying deficiency in heme synthesis. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.

At a glance

Generic nameHEMIN
ModalitySmall molecule
Therapeutic areaNeuroscience
PhaseFDA-approved

Mechanism of action

Heme acts to limit the hepatic and/or marrow synthesis of porphyrin. This action is likely due to the inhibition of -aminolevulinic acid synthetase, the enzyme which limits the rate of the porphyrin/heme biosynthetic pathway. The exact mechanism by which hematin produces symptomatic improvement in patients with acute episodes of the hepatic porphyrias has not been elucidated.PANHEMATIN therapy for the acute porphyrias is not curative. After discontinuation of PANHEMATIN treatment, symptoms generally return although in some cases remission is prolonged. Some neurological symptoms have improved weeks to months after therapy although little or no response was noted at the time of treatment.

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

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