Hemin

Overview

Hemin (trade name Panhematin) is an iron-containing porphyrin. More specifically, it is protoporphyrin IX containing a ferric iron ion (heme B) with a chloride ligand.

Indication

Used in the management of porphyria attacks, particularly in acute intermittent porphyria.

Associated Conditions

Acute Porphyria
Hereditary Coproporphyria (HCP)
Variegate Porphyria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Acute Porphyria Biomarkers for Disease Activity	2016/10/17	NCT02935400	N/A	Active, not recruiting	The University of Texas Medical Branch, Galveston
Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria	2014/07/02	NCT02180412	Phase 2	Completed	The University of Texas Medical Branch, Galveston
Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis	2013/05/17	NCT01855841	Phase 2	Completed	Erasme University Hospital
Hemin in Healthy Subjects	2009/04/17	NCT00882804	Phase 1	Completed	Mayo Clinic
Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS	2007/04/30	NCT00467610	Phase 2	Terminated	Rush University Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Panhematin	RECORDATI RARE DISEASES, INC.	55292-702	INTRAVENOUS	7 mg in 1 mL	2/14/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PANHEMATIN	recordati rare diseases canada inc	02478765	Powder For Solution - Intravenous	268 MG / VIAL	12/5/2018

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NORMOSANG 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION	Recordati Rare Diseases	63116	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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