IP Library › Granted Patent US 12,636,271
Granted Patent B2
US 12,636,271 · App. 17/940,958 · Granted May 26, 2026

Combination comprising N-acetyl-L-cysteine and its use

Inventors: Tiziana Parasassi (Rome, IT); Graziella Costa (Ciampino, IT); Ewa Krasnowska (Rome, IT); Eugenia Pittaluga (Rome, IT); Thomas Lundeberg (Lidingö, SE)
Assignee: IASOMAI AB
A61K31/28A61K8/23A61K8/447A61K8/4913A61K8/58A61K8/63A61K31/198A61K31/4045A61K31/573A61K45/06A61L29/08A61Q19/08Y02A50/30
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Quick Facts
Patent No.
US 12,636,271
App. No.
17/940,958
Granted
May 26, 2026
Kind
B2
Abstract

A combination of N-acetyl-L-cysteine, selenium in the form of selenomethionine and melatonin, and a medical product or pharmaceutical composition comprising such combination, useful for the treatment of a variety of diseases and conditions is described. The combination of N-acetyl-L-cysteine, selenium in the form of selenomethionine and melatonin is also useful for cosmetic treatment of skin and as an antibacterial agent.

Claims (21)

1 . A method of treating an anxiety disorder, the method comprising:

administering to a patient in need thereof, a medical product consisting of one or more excipients and active agents consisting of:

(i) N-acetyl-L-cysteine;

(ii) selenium in the form of selenomethionine; and

(iii) melatonin

and/or physiologically acceptable salts thereof.

2 . The method of claim 1 , wherein the anxiety disorder is sporadic insomnia.

3 . The method of claim 1 , wherein the anxiety disorder is fatigue.

4 . The method of claim 1 , wherein the medical product consisting of one or more excipients and active agents consisting of N-acetyl-L-cysteine, selenomethionine, and melatonin and/or physiologically acceptable salts thereof is administered orally.

5 . The method of claim 1 , wherein components (i)-(iii) are provided as separate dosage units.

6 . The method of claim 1 , wherein the N-acetyl-L-cysteine is administered at a dose of 45 mg/kg/day, the selenomethionine is administered at a dose of 0.4-1.2 μg/kg/day, and the melatonin is administered at a dose of 0.02-0.08 mg/kg/day.

7 . The method of claim 6 , wherein the N-acetyl-L-cysteine is administered at a dose of 20-30 mg/kg/day, the selenomethionine is administered at a dose of 0.8 μg/kg/day, and the melatonin is administered at a dose of 0.04 mg/kg/day.

8 . The method of claim 1 , wherein the N-acetyl-L-cysteine is administered at a dose of about 500 mg/day to about 3000 mg/day, the selenomethionine is administered at a dose of about 20 μg/day to about 200 μg/day, and the melatonin is administered at a dose of about 1 to about 10 mg/day.

9 . The method of claim 8 , wherein the selenomethionine is administered at a dose of about 55 μg/day, and the melatonin is administered at a dose of about 3 mg/day.

10 . The method of claim 1 , wherein the anxiety disorder is selected from the group consisting of generalized anxiety disorder (GAD), panic disorder, social phobia, agoraphobia, obsessive-compulsive disorder (OCD), posttraumatic stress disorder, sporadic insomnia and/or fatigue.

11 . The method of claim 1 , wherein the anxiety disorder is generalized anxiety disorder (GAD).

12 . The method of claim 1 , wherein the anxiety disorder is panic disorder.

13 . The method of claim 1 , wherein the anxiety disorder is social phobia.

14 . The method of claim 1 , wherein the anxiety disorder is agoraphobia.

15 . The method of claim 1 , wherein the anxiety disorder is obsessive-compulsive disorder (OCD).

16 . The method of claim 1 , wherein the anxiety disorder is posttraumatic stress disorder.

Priority Claims (2)
SE 1100238-3 · Apr 1, 2011 · national
SE 1150696-1 · Jul 15, 2011 · national
Continuity (8)
Continuation In Part 17560902 · Dec 23, 2021
Continuation 16401621 · May 2, 2019
Continuation 15791290 · Oct 23, 2017
Division 14042282 · Sep 30, 2013
Continuation PCTEP2012054360 · Mar 13, 2012
Provisional Application 61508262 · Jul 15, 2011
Provisional Application 61471162 · Apr 3, 2011
Related Publication 20230226009A1 · Jul 20, 2023
References Cited (58)
US 4746674A · Pierpaoli et al. · 1988 [cited by applicant]
US 5330757A · Burke · 1994 [cited by applicant]
US 5667791A · Hersh et al. · 1997 [cited by applicant]
US 5804594A · Murad · 1998 [cited by applicant]
US 6207190B1 · Richardson et al. · 2001 [cited by applicant]
US 8637573B2 · Parasassi et al. · 2014 [cited by applicant]
US 9585854B2 · Lundeberg · 2017 [cited by applicant]
US 20030229141A1 · Yu et al. · 2003 [cited by applicant]
US 20040001817A1 · Giampapa · 2004 [cited by applicant]
US 20040045566A1 · Pera · 2004 [cited by applicant]
US 20050164911A1 · Cavalieri et al. · 2005 [cited by applicant]
US 20070231312A1 · Muench et al. · 2007 [cited by applicant]
US 20100015200A1 · McClain et al. · 2010 [cited by applicant]
US 20110027771A1 · Deng · 2011 [cited by applicant]
CA 2230389 · 1999 [cited by applicant]
DE 10110418 · 2002 [cited by applicant]
EP 0438856 · 1991 [cited by applicant]
JP H1072339 · 1998 [cited by applicant]
JP H11286442 · 1999 [cited by applicant]
JP 2001151153 · 2001 [cited by applicant]
JP 2005539056 · 2005 [cited by applicant]
JP 2009506030 · 2009 [cited by applicant]
WO WO1998033494 · 1998 [cited by applicant]
WO WO2002051405 · 2002 [cited by applicant]
WO WO2003077900 · 2003 [cited by applicant]
WO WO2003105797 · 2003 [cited by applicant]
WO WO2005013951 · 2005 [cited by applicant]
Bradlow et al. (The potential of N-Acetyl-L-Cysteine (NAC) in the treatment of Psychiatric Disorders, CNS Drugs, Mar. 22, 2022; 36(5). [cited by examiner]
“Welcome to NCBI The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.”, National Center for Biotechnology Information, Mar. 30, 2011, 1… [cited by applicant]
Akbaraly et al., “Plasma selenium and risk of dysglycemia in an elderly French population: results from the prospective Epidemiology of Vascular Ageing Study”, Nutrition & Metabolism, 2010, pp. 1-7, vol. 7, No. 21, BioM… [cited by applicant]
Balansky et al., “Interactions Between N-Acetylcysteine and Sodium Selenite in Modulating the Clastogenicity of Urethane and 2-Acetylaminofluorene in Mice”, International Journal of Cancer, 2004, pp. 158-161, vol. 108, … [cited by applicant]
Bulato et al., “Effect of mercury on selenium utilization and selenoperoxidase activity in LNCaP cells”, Free Radical Biology & Medicine, 2007, pp. 118-123, vol. 42, Elsevier, Amsterdam, Netherlands. [cited by applicant]
Cemeli et al., “Antioxidants and the Comet assay”, Mutation Research, 2009, pp. 51-67, vol. 681, Elsevier, Amsterdam, Netherlands. [cited by applicant]
Chantret et al., “Differential expression of sucrase-isomaltase in clones isolated from early and late passages of the cell line Caco-2: evidence for glucose-dependent negative regulation”, Journal of Cell Science, 1994… [cited by applicant]
Emonet et al., “Thiols and selenium: protective effect on human skin fibroblasts exposed to UVA radiation.” (Abstract Only), PubMed, Aug. 1997, 1 page [online], [retrieved on Jan. 12, 2010]. Retrieved from the Internet:… [cited by applicant]
García et al., “Protective role of melatonin on oxidative stress status and RNA expression in cerebral cortex and cerebellum of AbetaPP transgenic mice after chronic exposure to aluminum.” (Abstract Only), Jun. 2010, Pu… [cited by applicant]
Gustafsson et al. “Global gene expression analysis in time series following N-acetyl L-cysteine induced epithelial differentiation of human normal and cancer cells in vitro” BMC Cancer, 5:75, Jul. 7, 2005, pp. 1-19. [cited by applicant]
Halder et al., “Vitiligo Update”, Seminars in Cutaneous Medicine and Surgery, 2009, pp. 86-92, vol. 28, Elsevier, Amsterdam, Netherlands. [cited by applicant]
Hardeland et al., “Melatonin—A pleiotropic, orchestrating regulator molecule”, Progress in Neurobiology, 2011, pp. 350-384, vol. 93, Elsevier, Amsterdam, Netherlands. [cited by applicant]
Radogna et al., “Rapid and transient stimulation of intracellular reactive oxygen species by melatonin in normal and tumor leukocytes”, Toxicology and Applied Pharmacology, May 12, 2009, pp. 37-45, vol. 239, Elsevier, A… [cited by applicant]
Jones, Dean P., “Radical-free biology of oxidative stress”, American Journal of Physiology—Cell Physiology, Oct. 2008, pp. C849-C868, vol. 295, American Physiological Society, Bethesda, MD. [cited by applicant]
Klein, Eric A., “Selenium and Vitamin E: Interesting Biology and Dashed Hope”, Journal of the National Cancer Institute, Mar. 4, 2009, pp. 283-285, vol. 101, Issue 5, Oxford University Press, Oxford, Great Britain. [cited by applicant]
Krasnowska et al. “N-acetyl-I-cysteine fosters inactivation and transfer to endolysosomes of c-Src” Free Radical Biology & Medicine, vol. 45, No. 11, Sep. 23, 2008, pp. 1566-1572 (7 total). [cited by applicant]
Lippman et al., “Effect of Selenium and Vitamin E on Risk of Prostate Cancer and Other Cancers The Selenium and Vitamin E Cancer Prevention Trial (SELECT)”, Journal of American Medical Association, Jan. 7, 2009, pp. 39-… [cited by applicant]
Livak et al., “Analysis of Relative Gene Expression Data Using Real-Time Quantitative PCR and the 2(-Delta Delta C(T)) Method”, Methods, 2001, pp. 402-408, vol. 25, Elsevier Science (USA), New York, NY. [cited by applicant]
Look et al., “Sodium selenite and N-acetylcysteine in antiretroviral-naive HIV-1-infected patients: a randomized, controlled pilot study.” (Abstract Only), May 1998, 1 page [online], [retrieved on Jan. 12, 2010]. Retrie… [cited by applicant]
Nickel et al., “Tobramycin Resistance of Pseudomonas aeruginosa Cells Growing as a Biofilm on Urinary Catheter Material”, Antimicrobial Agents and Chemotherapy, Apr. 1985, pp. 619-624, vol. 27, No. 4, American Society f… [cited by applicant]
Parasassi et al. “Differentiation of normal and cancer cells induced by sulfhydryl reduction: biochemical and molecular mechanisms” Cell Death and Differentiation, vol. 12, No. 10, May 27, 2005, pp. 1285-1296 (12 total). [cited by applicant]
Parasassi et al., “Thiol Redox Transitions in Cell Signaling: a Lesson from N-Acetylcysteine”, The Scientific World Journal, 2010, pp. 1192-1202, vol. 10, TheScientificWorld, Cairo, Egypt. [cited by applicant]
Patent Office Of The Russian Federation, Office Action, Jan. 25, 2016, 5 pages, Russian Application No. 2013146213/15, filed Jul. 17, 2000. [cited by applicant]
PCT International Search Report, PCT Patent Application No. PCT/EP2012/054360, Jul. 3, 2012, 7 pages. [cited by applicant]
Pendyala et al. “Pharmacokinetic and Pharmacodynamic Studies of N-Acetylcysteine, a Potential Chemopreventive Agent during a Phase I Trial” Cancer Epidemiology, Biomarkers & Prevention, vol. 4, No. 3, Apr./May 1995, pp.… [cited by applicant]
Safarinejad et al., “Efficacy of selenium and/or N-acetyl-cysteine for improving semen parameters in infertile men: a double-blind, placebo controlled, randomized study.” (Abstract Only), 2009, 1 page [online], [retriev… [cited by applicant]
Sardar et al., “Antioxidant associated chemoprevention by selenomethionine in murine tumor model”, Molecular and Cellular Biochemistry, 2000, pp. 17-25, vol. 206, Netherlands. [cited by applicant]
Sener et al., “Melatonin and N-acetylcysteine have beneficial effects during hepatic ischemia and reperfusion”, Life Sciences, 2003, pp. 2707-2718, vol. 72, Elsevier, Amsterdam, Netherlands. [cited by applicant]
Setaro et al., “Irregularity skin index (ISI): a tool to evaluate skin surface texture”, Skin Research and Technology, 2001, pp. 159-163, vol. 7, Munksgaard, Copenhagen, Denmark. [cited by applicant]
Wölfler et al., “Prooxidant activity of melatonin promotes fas-induced cell death in human leukemic Jurkat cells”, Federation of European Biochemical Societies, 2001, pp. 127-131, vol. 502, Elsevier, Amsterdam, Netherla… [cited by applicant]
Yalçin et al., “Synergistic action of sodium selenite and N-acetylcysteine in acetaminophen-induced liver damage.” (Abstract Only), May 2008, 1 page [online], [retrieved on Jan. 12, 2010]. Retrieved from the Internet: <… [cited by applicant]