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Heme arginate + L-arginine
Heme arginate replenishes depleted heme pools while L-arginine provides substrate for nitric oxide synthesis, together improving endothelial function and reducing vasoconstriction in acute porphyria crises.
Heme arginate replenishes depleted heme pools while L-arginine provides substrate for nitric oxide synthesis, together improving endothelial function and reducing vasoconstriction in acute porphyria crises. Used for Acute intermittent porphyria (acute attack management), Variegate porphyria (acute attack management), Hereditary coproporphyria (acute attack management).
At a glance
| Generic name | Heme arginate + L-arginine |
|---|---|
| Sponsor | Radboud University Medical Center |
| Drug class | Heme replacement therapy with nitric oxide donor |
| Target | ALA synthase (indirect inhibition via heme feedback); nitric oxide synthase (L-arginine substrate) |
| Modality | Small molecule |
| Therapeutic area | Metabolic/Genetic disorders |
| Phase | FDA-approved |
Mechanism of action
In acute intermittent porphyria and related acute porphyrias, heme deficiency triggers overproduction of toxic porphyrin precursors. Heme arginate (a heme-albumin complex) directly replenishes heme and suppresses ALA synthase, the rate-limiting enzyme in porphyrin synthesis. L-arginine augments this effect by serving as a substrate for nitric oxide synthase, promoting vasodilation and reducing the hypertensive and vasoconstrictor complications characteristic of acute porphyria attacks.
Approved indications
- Acute intermittent porphyria (acute attack management)
- Variegate porphyria (acute attack management)
- Hereditary coproporphyria (acute attack management)
Common side effects
- Phlebitis at infusion site
- Headache
- Hypertension
- Nausea
Key clinical trials
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 + L-arginine CI brief — competitive landscape report
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- Radboud University Medical Center portfolio CI