Cysteine

Generic Name: Cysteine

Brand Names: Elcys, Freamine 6.9, Freamine III 10, Hepatamine 8, Nephramine, Nouress, Premasol, Primene, Procalamine 3, Trophamine 10 %

Drug Type: Small Molecule

Chemical Formula: C_₃H_₇NO_₂S

CAS Number: 52-90-4

Unique Ingredient Identifier: K848JZ4886

Overview

A thiol-containing non-essential amino acid that is oxidized to form cystine.

Indication

For the prevention of liver damage and kidney damage associated with overdoses of acetaminophen

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi	2025/07/10	NCT07058090	Not Applicable	Not yet recruiting	Liaquat National Hospital & Medical College
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease	2025/04/04	NCT06909799	Not Applicable	Recruiting	The Aurum Institute NPC
The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients	2025/02/20	NCT06836128	Phase 3	Recruiting	Cairo University
Chlorhexidine Versus N-Asetil Sistein Irrigation in Mandibular Molar Teeth with Chronic Apical Periodontitis	2025/02/19	NCT06834711	Not Applicable	Completed	Cukurova University
N-acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement	2024/07/05	NCT06486805	Phase 4	Completed	Kasr El Aini Hospital
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis	2024/07/03	NCT06484530	Phase 4	Recruiting	Mahidol University
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis	2024/07/01	NCT06482034	Phase 2	Completed	Mansoura University
Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair	2024/04/25	NCT06384833	Phase 4	Not yet recruiting	Mahidol University
Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients	2024/03/07	NCT06297369	Phase 2	Recruiting	Ain Shams University
Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis	2024/02/09	NCT06252441	Phase 1	Recruiting	Tanta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ELCYS	Exela Pharma Sciences, LLC	51754-1007	INTRAVENOUS	10 mg in 1 mL	2/1/2024
Premasol - sulfite-free (Amino Acid)	Baxter Healthcare Corporation	0338-1131	INTRAVENOUS	0.014 g in 100 mL	8/4/2022
TrophAmine	B. Braun Medical Inc.	0264-1933	INTRAVENOUS	0.024 g in 100 mL	8/22/2022
Bio Co Enzyme Phase	Deseret Biologicals, Inc.	43742-2259	ORAL	6 [hp_X] in 1 mL	4/8/2025
ELCYS	Exela Pharma Sciences, LLC	51754-1008	INTRAVENOUS	50 mg in 1 mL	2/1/2024
CYSTEINE HYDROCHLORIDE	Baxter Healthcare Corporation	0338-9645	INTRAVENOUS	34.5 mg in 1 mL	4/29/2022
Metox	Deseret Biologicals, Inc.	43742-1312	ORAL	6 [hp_X] in 1 mL	5/27/2025
Immuno-Boost	Parasitology Center, Inc.	70321-0002	ORAL	6 [hp_C] in 1 mL	5/22/2025
Premasol - sulfite-free (Amino Acid)	Baxter Healthcare Corporation	0338-1130	INTRAVENOUS	0.016 g in 100 mL	8/4/2022
MetDetox	Dr. Donna Restivo DC	62185-0062	ORAL	6 [hp_X] in 1 mL	5/23/2025

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
TROPHAMINE INJECTION 10%	B BRAUN MEDICAL INC	SIN07846P	INJECTION	0.016 g/100 ml	9/12/1994
VAMINOLACT INTRAVENOUS SOLUTION	FRESENIUS KABI AUSTRIA GMBH	SIN07428P	INJECTION	1 g/1000 ml	5/12/1993
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION	BIEFFE MEDITAL S.P.A.	SIN10252P	INJECTION	1.89 g/l	9/23/1998
AMINOSTERIL N-HEPA FOR INTRAVENOUS INFUSION 8%	FRESENIUS KABI AUSTRIA GMBH	SIN10000P	INJECTION	0.52 g/l	9/15/1998
NEPHROSTERIL FOR INTRAVENOUS INFUSION	FRESENIUS KABI AUSTRIA GMBH	SIN06299P	INJECTION	0.37 g/l	6/21/1991

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
VAMINOLACT I.V. SOLUTION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	10/14/1992

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Mediherb P2-Detox	218993	Integria Healthcare Australia Pty Ltd	Medicine	A	1/8/2014
Crystal-Skin White Plus	371583	Aus Nature Pharmaceuticals Pty Ltd	Medicine	A	7/23/2021
USANA HealthPak	350153	Usana Australia Pty Ltd	Medicine	A	11/30/2020
Dr. Nature Hangover Relief Before Meal	418109	Health Sharing Group Pty Ltd	Medicine	A	8/14/2023
ETHICAL NUTRIENTS EXTRA C 1000mg POWDER	374472	Metagenics (Aust) Pty Ltd	Medicine	A	9/10/2021
ElementAll Diet	447331	Factors Group Australia Pty Ltd	Medicine	A	5/1/2024
Hangover Relief 12 in 1	482385	Nutrition 29 Pty Ltd	Medicine	A	3/13/2025
Hair Growth & Thickness	378750	Pharmacare Laboratories Pty Ltd	Medicine	A	11/24/2021
Total Detox + Kidney Support	440312	TLCH Import and Export Pty Ltd	Medicine	A	2/8/2024
Biotin Hair Supplement	418352	Skin Software Pty Ltd	Medicine	A	8/17/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PRIMENE 10%	baxter corporation	02236875	Liquid - Intravenous	189 MG / 100 ML	11/14/1997
CICATRIN POWDER	GlaxoSmithKline Inc	00666173	Powder - Topical	2 MG / G	12/31/1987
VAMIN 18 ELECTROLYTE-FREE	Fresenius Kabi AB	02059711	Solution - Intravenous	56 MG / 100 ML	12/30/1996
AMINODERM POUDRE	desbergers ltée, division of technilab inc.	00086649	Powder - Topical	2 MG / G	12/31/1968

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NUMETA G19%E, EMULSION PARA PERFUSION	Baxter S.L.	74020	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
NUMETA G13% E EMULSION PARA PERFUSION	Baxter S.L.	81161	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
NUMETA G16%E, EMULSION PARA PERFUSION	Baxter S.L.	74019	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VAMIN 18 SIN ELECTROLITOS SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	59878	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PRIMENE 10% SOLUCIÓN PARA PERFUSIÓN	Baxter S.L.	58115	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
AMINOSTERIL N-HEPA 8% SOLUCION PARA PERFUSION INTRAVENOSA	Fresenius Kabi España, S.A.U.	59669	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VAMIN 14 SIN ELECTROLITOS SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	59885	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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