Author(s): Narendra Kumar S, Neethi V Gandhi, Nishanth Sarode, Pranay Prasad, Riya Prince, Shivandappa

Email(s): narendraks@rvce.edu.in

DOI: 10.52711/0974-360X.2026.00046   

Address: Narendra Kumar S*, Neethi V Gandhi, Nishanth Sarode, Pranay Prasad, Riya Prince, Shivandappa
Department of Biotechnology, R.V. College of Engineering, Bengaluru, Karnataka, India.
*Corresponding Author

Published In:   Volume - 19,      Issue - 1,     Year - 2026


ABSTRACT:
Itolizumab, a humanized recombinant monoclonal antibody targeting the SRCR-D1 region of CD6, exhibits therapeutic potential in various medical conditions. This review encompasses its molecular characteristics, pharmacokinetics, pharmacodynamics, mechanism of action and the production flow chart. Commercially available as Alzumab™, Itolizumab's linear, dose- dependent relationship in Cmax, increased accumulation with higher dosing frequency, and variable half-life reveal key pharmacokinetic features. Itolizumab's safety margin is established through toxicity studies, and its suggested dosage is outlined. Itolizumab emerges as a versatile therapeutic option, demonstrating efficacy in autoimmune disorders, infectious diseases like COVID-19, and chronic conditions like psoriasis, rheumatoid arthritis and diabetes, Multiple Sclerosis (MS) and Inflammatory Bowel Disease (IBD). Further structural exploration and clinical trials are warranted to explore its therapeutic potential and elucidate its long-term safety profile.


Cite this article:
Narendra Kumar S, Neethi V Gandhi, Nishanth Sarode, Pranay Prasad, Riya Prince, Shivandappa. Therapeutic Potential of Itolizumab: Mechanisms, Efficacy and Clinical Applications. Research Journal of Pharmacy and Technology. 2026;19(1):319-4. doi: 10.52711/0974-360X.2026.00046

Cite(Electronic):
Narendra Kumar S, Neethi V Gandhi, Nishanth Sarode, Pranay Prasad, Riya Prince, Shivandappa. Therapeutic Potential of Itolizumab: Mechanisms, Efficacy and Clinical Applications. Research Journal of Pharmacy and Technology. 2026;19(1):319-4. doi: 10.52711/0974-360X.2026.00046   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-1-46


REFERENCES: 
1.    Srivastava A. Itolizumab in Psoriasis. Indian J Dermatol. 2017; Jul 1; 62(4): 418–21. DOI: 10.4103/ijd.IJD_467_16
2.    Krupashankar DS, Dogra S, Kura M, Saraswat A, Budamakuntla L, Sumathy TK, et al. Efficacy and safety of itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: results of a double-blind, randomized, placebo-controlled, phase-III study. J Am Acad Dermatol. 2014; 71(3): 484–92. DOI: 10.1016/j.jaad.2014.01.897
3.    Menon R, David BG. Itolizumab – a humanized anti-CD6 monoclonal antibody with a better side effects profile for the treatment of psoriasis. Clin Cosmet Investig Dermatol. 2015; Apr 17; 8:215. doi: 10.2147/CCID.S47784
4.    Shinde AD, Bhise SB, Optimization of Pharmacokinetic By Loading Bioenhancer in Optimized Nasal Mucoadhesive Microspheres of Insulin. Res J Pharm Technol. 2010; 3(2): 613-618. Available from: https://rjptonline.org/HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmacy%20and%20Technology;PID=2010-3-2-60
5.    Kachariya Brijesh, Vihar Gadhvi, Amit Gupta, Komal Roopchandani, Nirav Patel. A Review: Production of Monoclonal Antibody. Res J Pharm Technol. 2013; 6(7): 701-705. Available from: https://rjptonline.org/AbstractView.aspx?PID=2013-6-7-1
6.    Montazersaheb S, Hosseiniyan Khatibi SM, Hejazi MS, Tarhriz V, Farjami A, Ghasemian Sorbeni F, et al. COVID-19 infection: an overview on cytokine storm and related interventions. Virol J. 2022; Dec 1; 19(1): 92. doi: 10.1186/s12985-022-01814-1 
7.    Atal S, Fatima Z, Balakrishnan S. Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour? BioDrugs. 2020; Dec 1; 34(6): 705–11. DOI: 10.1007/s40259-020-00448-5
8.    Sura NK, Hiremath L. Hydroxycitric Acid (Hca)-A Potent Nutraceuticals. Res J Pharm Technol. 2019; Jul 25; 12(7): 3163–8. DOI: 10.5958/0974-360X.2019.00533.X
9.    Narendra Kumar S, Hiremath L, Gupta PK, Srivastava AK, Poornima S. Industrial Purification Strategies for Monoclonal Antibodies. Res J Pharm Technol. 2017; Oct 30; 10(10): 3561–6. DOI: 10.5958/0974-360X.2017.00645.X 
10.    Srivastava K, Singh MK. Drug repurposing in COVID-19: A review with past, present and future. Metabol Open. 2021; Dec; 12: 100121. DOI: 10.1016/j.metop.2021.100121
11.    Sura NK, Lal VS, Rajeev A. Production of Alkaline Serine Protease from Bacillus subtilis MTCC 8601. Res J Pharm Technol. 2024; Sep 24; 17(9): 4161–8. DOI: 10.52711/0974-360X.2024.00644.
12.    Aira LE, Loṕez-Requena A, Fuentes D, Sańchez L, Peŕez T, Urquiza A, et al. Immunological and histological evaluation of clinical samples from psoriasis patients treated with anti-CD6 itolizumab. MAbs. 2014; 6(3): 782–92. DOI: 10.4161/mabs.28376
13.    Sakthi Priyadarsini S, Vani PB, Kumar PR. A Comparative Review on Conventional and Traditional medicine in the Treatment of Psoriasis. Res J Pharm Technol. 2020; Nov 13; 13(11): 5642–6. DOI: 10.5958/0974-360X.2020.00983.X 
14.    Pai G, Pai AH. Itolizumab – A New Biologic for Management of Psoriasis and Psoriatic Arthritis. Case Rep Dermatol. 2017; Dec 23; 9(2): 141. doi: 10.1159/000475519 
15.    Parasramani SG. Itolizumab in the Management of Psoriasis with Metabolic Syndrome. J Clin Diagn Res. 2017; Jul 1; 11(7): WD01–2. DOI: 10.7860/JCDR/2017/25490.10300
16.    Kumar N, Rathinasamy M, Kumar A, Kumar A, Singh K. Severe bronchospasm following itolizumab infusion in a COVID-19 patient. J Anaesthesiol Clin Pharmacol. 2022; 38(Suppl 1): 157. DOI: 10.4103/joacp.JOACP_675_20
17.    Kurri N, Tyagi B, Kaushik A, Gupta N, Agarwal AK, Singh BM. Role of Itolizumab in the Treatment of COVID-19 Patients, Admitted to ICU at a Tertiary Care Hospital. J Assoc Physicians India. 2022; Oct 1; 70(10): 11–2. DOI: 10.5005/japi-11001-0114
18.    Vityala Y, Tagaev T, Mamatov S, Aidarov Z, Harinath P. Potential effects of itolizumab treatment on plasma interleukin-6 levels in patients with severe COVID-19. Indian J Pharmacol. 2021; May 1; 53(3): 246–7. DOI: 10.4103/ijp.IJP_33_21
19.    Kumari P, Kumar A, Sinha C, Kumar A, Singh PK, Arun SK. Off-label Use of Itolizumab in Patients with COVID-19 ARDS: Our Clinical Experience in a Dedicated COVID Center. Indian J Crit Care Med. 2021; Apr 1; 25(4): 467. DOI: 10.5005/jp-journals-10071-23787
20.    Thangaraju P, Venkatesan N, Thangaraju E, Venkatesan S. Are We Jumping the Gun with Itolizumab in India? A Situational Analysis from the Pre-COVID Era. SN Compr Clin Med. 2020; Nov; 2(11): 2131–6. DOI: 10.1007/s42399-020-00550-3
21.    Cabrera-Rode E, Cubas-Dueñas I, Rodríguez-Acosta J, García-García Y, Torres-López Y, Prieto-Noa C, et al. An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes. J Clin Med. 2022; Apr 1; 11(7). DOI: 10.3390/jcm11071789
22.    Mohammed Z, Suryachandra K, Dandekar MP. Adverse drug reactions of itolizumab in COVID-19 patient: A case report. Indian J Pharmacol. 2022; Sep 1; 54(5): 377–8. DOI: 10.4103/ijp.ijp_803_21
23.    D Kilimozhi, V Parthasarathy, Manavalan R. A Review on Arthritis. Res J Pharm Technol. 2011; 4(1): 29-36. Available from: https://rjptonline.org/AbstractView.aspx?PID=2011-4-1-26
24.    Rodríguez PC, Prada DM, Moreno E, Aira LE, Molinero C, López AM, et al. The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial. Clin Exp Immunol. 2018; 191(2): 229–39. DOI: 10.1111/cei.13061
25.    Nandgude TD, Hasabe PS, Kolsure AK. Clinical Features and Treatment of Rheumatoid Arthritis: A Review. Res J Pharm Technol. 2018; Dec 31; 11(12): 5701–6. Available from: https://rjptonline.org/AbstractView.aspx?PID=2018-11-12-81
26.    Aira LE, Hernández P, Prada D, Chico A, Gómez JA, González Z, et al. Immunological evaluation of rheumatoid arthritis patients treated with itolizumab. MAbs. 2016; Jan 1; 8(1): 187–95. DOI: 10.1080/19420862.2015.1105416
27.    S.K A, Vijey Aanandhi M. An Improvement in Patient Compliance in Diabetes Mellitus. Res J Pharm Technol. 2018; Feb 28; 11(2): 587–92. DOI: 10.5958/0974-360X.2018.00108.7 
28.    Diaz Y, Ramos-Suzarte M, Martín Y, Calderón NA, Santiago W, Viñet O, et al. Use of a Humanized Anti-CD6 Monoclonal Antibody (Itolizumab) in Elderly Patients with Moderate COVID-19. Gerontology. 2020; Dec 1; 66(6): 553–61. DOI: 10.1159/000512210
29.    Biocon share hits all-time high after drug Itolizumab gets DCGI nod for Covid treatment - BusinessToday. Available from: https://www.businesstoday.in/markets/company-stock/story/biocon-share-all-time-high-itolizumab-dcgi-covid-treatment-263861-2020-07-13
30.    Alaraj M. Pharmacological repurposed agents for COVID-19. Res J Pharm Technol. 2022; Jan 25; 15(1): 441–6. DOI: 10.52711/0974-360X.2022.00073
31.    Nandgude TD, Hasabe PS, Kolsure AK. Clinical Features and Treatment of Rheumatoid Arthritis: A Review. Res J Pharm Technol. 2018; Dec 31; 11(12): 5701–6. DOI: 10.5958/0974-360X.2018.01032.6 
32.    Samidha Kamtekar, Vrushali Keer. Management of Diabetes: A Review. Res J Pharm Technol. 2014; 7(9): 1065-1072. Available from: https://rjptonline.org/HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmacy%20and%20Technology;PID=2014-7-9-15

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