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Heme arginate (Normosang)
Heme arginate replenishes depleted heme pools and inhibits delta-aminolevulinic acid synthase (ALAS1) to reduce the toxic accumulation of porphyrin precursors in acute porphyria attacks.
Heme arginate replenishes depleted heme pools and inhibits delta-aminolevulinic acid synthase (ALAS1) to reduce the toxic accumulation of porphyrin precursors in acute porphyria attacks. Used for Acute intermittent porphyria (acute attack), Variegate porphyria (acute attack), Hereditary coproporphyria (acute attack).
At a glance
| Generic name | Heme arginate (Normosang) |
|---|---|
| Also known as | Heme Arginate, Hemin |
| Sponsor | University of Edinburgh |
| Drug class | Heme supplement |
| Target | Delta-aminolevulinic acid synthase 1 (ALAS1) |
| Modality | Small molecule |
| Therapeutic area | Metabolic/Genetic Disorders |
| Phase | Phase 3 |
Mechanism of action
In acute intermittent porphyria and other acute porphyrias, overproduction of toxic porphyrin precursors (ALA and PBG) causes severe neurovisceral symptoms. Heme arginate provides exogenous heme, which suppresses ALAS1 activity through negative feedback, thereby reducing precursor synthesis and alleviating acute attack symptoms. This mechanism addresses the underlying biochemical defect rather than treating symptoms alone.
Approved indications
- Acute intermittent porphyria (acute attack)
- Variegate porphyria (acute attack)
- Hereditary coproporphyria (acute attack)
Common side effects
- Phlebitis or injection site reactions
- Transient fever
- Headache
- Nausea
Key clinical trials
- Heme Arginate in Transplantation Study (PHASE3)
- Heme Arginate in Cardiac Surgery Patients (PHASE2)
- A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP) (PHASE1, PHASE2)
- Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis (PHASE2)
- The Effects of Intravenous Heme Arginate on Heme Oxygenase-1 Expression (HO-1) and Oxidative Stress in the Human Heart (PHASE2)
- Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation (PHASE3)
- Effects of Heme Arginate in Healthy Male Subjects (PHASE1)
- Heme Arginate in Functional Magnetic Resonance Imaging (fMRI) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Heme arginate (Normosang) CI brief — competitive landscape report
- Heme arginate (Normosang) updates RSS · CI watch RSS
- University of Edinburgh portfolio CI