Innovation Excellence is unleashed when ideas are spurred by action, making the impossible happen.

As a research-based pharmaceutical company, Zydus' Innovation programme is spearheaded by 1300 researchers across 19 sites, working on differentiated medicines for the future. From NCEs to vaccines, biosimilars and niche technologies, the group is exploring different ideas, concepts and continuously innovating.

Major Areas of Research:

NCE Research NCE RESEARCH
  • Cardio-Metabolic diseases
  • Inflammation & pain
  • Oncology
Biologics BIOLOGICS
  • Biosimilar Therapeutic proteins
  • Biosimilar Monoclonal antibodies
  • Biobetters and Novel biologics
Vaccines VACCINES
  • Infectious diseases
Research Spectrum

NEW CHEMICAL ENTITIES

The Zydus Research Centre (ZRC) is the dedicated research arm of the Zydus Group. With its team of over 400 research professionals, ZRC spearheads the group’s quest of creating healthier and happier communities globally. Spread over an area of over 4,75,000 sq ft, ZRC is working on cutting edge technologies in different scientific disciplines to discover novel therapeutic agents. The centre has capabilities to conduct drug discovery & development from concept to IND enabling preclinical and clinical studies.

In 2013, the group was the first to identify, develop and launch LipaglynTM (Saroglitazar) the novel drug to treat diabetic dyslipidemia – a global, unmet healthcare need. Lipaglyn is the first NCE from an Indian research pipeline to move from the lab to the market. It offers dual benefits of lipid and glycemic control in one single molecule. It is an innovation that has helped over 700000 people suffering from diabetic dyslipidemia in India lead healthier lives.

Saroglitazar Mg currently approved in India is a prescription medicine for the treatment of Hypertriglyceridemia, Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins, Type 2 Diabetes and Non-Alcoholic SteatoHepatitis (NASH) & Non Alcoholic Fatty Liver Disease (NAFLD) with comorbidities

Zydus Lipaglyn

Saroglitazar Mg is an investigational new drug in the United States of America, and is currently being evaluated in Phase II clinical trials for the treatment of Non-Alcoholic SteatoHepatitis (NASH). Zydus has completed enrolment of Phase 2b/3 EPICS III trial of Saroglitazar Mg in patients with Primary Biliary Cholangitis (PBC). The USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for Primary Biliary Cholangitis (PBC). Saroglitazar Mg has received Orphan Status from EMA for PBC.

Hypertriglyceridemia Diabetic Dyslipidemia Type 2 Diabetes NAFLD NASH PBC

* Saroglitazar is a prescription drug authorised for sale in India only and can be taken only under the advice and guidance of a registered medical practitioner.

PUBLICATIONS:

POSTERS AND PRESENTATIONS :

Current Status
Approved (India) Anemia in CKD
NDA (China) Anemia in CKD
Phase IIa (India) Sickle Cell Disease
Phase I (USA) Chemotherapy Induced Anemia (CIA)
Unmet Need
Anemia is a condition of having lower red blood cells or lower hemoglobin levels than is normal. Anemia is a serious medical condition linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). Currently available agents for the treatment of anemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. The estimated global market for treatments for anemia related to CKD is $ 10 billion.
Publications & Posters
1. Desidustat in Anemia due to Non- Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-ND). Am J Nephrol. 2022. DOI: 10.1159/000523961

2. Desidustat in Anemia due to Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-D). Am J Nephrol. 2022. DOI: 10.1159/000523949

3. Prolyl hydroxylase inhibitor desidustat improves anemia in erythropoietin hyporesponsive state. Current Research in Pharmacology and Drug Discovery. 2022; 100102. https://doi.org/10.1016/j.crphar.2022.100102.

4. Outcomes of Desidustat Treatment in People with Anemia and Chronic Kidney Disease: A Phase 2 Study. Am J Nephrol. 2019;49:470–478.

5. Phase I Clinical Study of ZYAN1, A Novel Prolyl-Hydroxylase (PHD) Inhibitor to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Oral Administration in Healthy Volunteers. Clin Pharmacokinet. 2018 Jan; 57(1):87-102.

6. Pharmacological Characterization of ZYAN1, a Novel Prolyl Hydroxylase Inhibitor for the Treatment of Anemia. Drug Res (Stuttg). 2016 Feb; 66(2):107-12.

7. Influence of acute and chronic kidney failure in rats on the disposition and pharmacokinetics of ZYAN1, a novel prolyl hydroxylase inhibitor, for the treatment of chronic kidney disease-induced anemia. Xenobiotica. 2018 Jan; 48(1):37-44.

8. A sensitive assay for ZYAN1 in human whole blood and urine utilizing positive LC-MS/MS electrospray ionization. Bioanalysis. 2017 May; 9(9):719-732.

9. Pharmacological inhibition of prolyl hydroxylase protects against inflammation-induced anemia via efficient erythropoiesis and hepcidin downregulation. Eur J Pharmacol. 2019 Jan 15; 843:113-120.

10. Prolyl Hydroxylase Inhibitors: A Breakthrough in the Therapy of Anemia Associated with Chronic Diseases. J Med Chem. 2018 Aug 23; 61(16):6964-6982.

11. Prolyl hydroxylase inhibitor desidustat protects against acute and chronic kidney injury by reducing inflammatory cytokines and oxidative stress. Drug Dev Res. 2021; 1–9.

12. Nonclinical Pharmacokinetic Evaluation of Desidustat: a Novel Prolyl Hydroxylase Inhibitor for the Treatment of Anemia, European Journal of Drug Metabolism and Pharmacokinetics. 2022 Jul 26. doi: 10.1007/s13318-022-00788-3

13. A Food-Effect Study to Evaluate the Oral Bioavailability of Desidustat. Clin Pharmacol Drug Dev. 2023 Apr;12(4):356-362. doi: 10.1002/cpdd.1206. Epub 2022 Dec 2. PMID: 36458679

14. HIF-PHD inhibitor desidustat ameliorates iron deficiency anemia. Toxicol Appl Pharmacol. 2024 Feb;483:116832. doi: 10.1016/j.taap.2024.116832. Epub 2024 Jan 22. PMID: 38266872.

15. HIF Stabilizer Desidustat Protects against Complement-Mediated Diseases. Drug Res (Stuttg). 2024 Jul 11. doi: 10.1055/a-2347-9919.

Potential Indication
indication
Current Status
Phase II Cryopyrin-Associated Periodic Syndrome (CAPS)
Phase II Amyotrophic Lateral Sclerosis
Phase II Ulcerative colitis
Phase II Parkinson’s Disease
Unmet Need
NLRP3 inflammasomes are involved in the inflammation process by production and release of proinflammatory cytokines IL-1β and IL-18. This harmful inflammation within the body leads to the onset and development of various kinds of diseases, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, Gastro-intestinal diseases (inflammatory bowel disease), renal diseases and CNS diseases. Currently most of the inflammatory disease are mainly treated by several approved biological drugs. A novel oral small molecule NLRP3 inhibitor like ZYIL1 with good safety profile has the potential to be the new standard of care for several inflammatory disease.
Publications
1. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First-in-Human Phase 1 Studies (Single Ascending Dose and Multiple Ascending Dose). Clin Pharmacol Drug Dev. 2022 Sep 5. doi: 10.1002/cpdd.1162. Epub ahead of print. PMID: 36065092.

2. Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 1–8. DOI: 10.1002/cpdd.1318.

3. A novel selective NLRP3 inhibitor shows disease-modifying potential in animal models of Parkinson's disease. Brain Res. 2024 Jul 27;1842:149129. doi: 10.1016/j.brainres.2024.149129.



BIOLOGICS

TwinrabTM

Rabies and its Prevalence

  • Rabies is an acute viral encephalomyelitis of humans and other warm-blooded vertebrates1
  • It is caused by a member of the genus Lyssavirus of the Rhabdoviridae family1
  • Rabies is almost always fatal, as it has one of the highest case fatality rates of any infectious disease2
  • In more than 99% of all cases of human rabies, the virus is transmitted from dogs2
  • Globally around 59,000 human rabies deaths occur every year of which about one-third – 20,000, occurs in India alone3
  • Globally, around 6 million people undergo post exposure treatment (PET) of rabies every year4
  • In India, around 17.4 million animal bites occur every year, among which only 5 million rabies undergo post exposure prophylaxis (PEP) are provided3

Post-exposure Prophylaxis

All the cases of rabies exposure should be treated immediately for the prevention of of clinical symptoms and death.

Post-exposure prophylaxis consists of:

  • Wound treatment
  • Administration of rabies vaccines based on WHO recommendations
  • Administration of rabies immunoglobulin (if indicated)

Zydus Twinrab

Passive Immunisation6

  • Passive immunization should be administered just before or shortly after administration of the first dose of vaccine given in the post-exposure prophylaxis regimen
  • If it is not immediately available, passive immunization can be administered up until the seventh day after initiation of the primary series of post-exposure prophylaxis (with cell-culture or embryonated-egg rabies vaccine)
  • Passive immunization should be administered just before or shortly after administration of the first dose of vaccine given in the post-exposure prophylaxis regimen
  • If it is not immediately available, passive immunization can be administered up until the seventh day after initiation of the primary series of post-exposure prophylaxis (with cell-culture or embryonated-egg rabies vaccine)

Unmet Need – Requirement of Anti-Rabies Monoclonal Antibodies

Although two types of RIGs (HRIGs and ERIGs) are available, they have the following drawbacks:

1. HRIG:1

  • Risk of infections
  • Very expensive and available in limited quantities
  • High Volume of Administration

2. ERIG:1

  • Risk of zoonotic infections
  • Production largely discontinued due to animal protection groups
  • High Volume of Administration7

Other limitations of HRIG and ERIG7

  • 1. High cost – <2% utilization world-wide
  • 2. Cold storage
  • 3. Potential shortages
  • 4. Potential blood borne pathogens – Virus inactivation steps required

TwinrabTM - World‘s First Anti-Rabies Monoclonal Antibody Cocktail

TwinrabTM is a cocktail of two anti-rabies monoclonal antibodies, indicated for the post-exposure prophylaxis (PEP) of contact with a rabid or suspected rabid animal.

Twinrab™ is an equipotent mixture of two monoclonal antibodies i.e. docaravimab (MAb 62-71-3) and miromavimab (MAb M777-16-3) binding to two distinct sites on the Rabies virus.

The hybridomas were sourced from the following WHO collaborating centres through NIBSC, United Kingdom:

  • Docaravimab (MAb 62-71-3) – Centres for Disease Control and Prevention (CDC), Atlanta, USA
  • Miromavimab (MAb M777-16-3) – Animal Diseases Research Institute (ADRI), Nepean, Canada

The individual monoclonal antibodies present in the Twinrab™ cocktail mixture were found to neutralize in vitro, various rabies and rabies related viruses such as (CVS 11, SAD B19, PV, Kelev, European Fox, Dog Turkey, Dog Ethiopia, Dog India, Dog Mexico, Wolf Sarajevo, Bobcat-USA, EBLV 1, EBLV 2, East European fox, Polar fox, Dog Azerbaijan, Dog Nepal).

In various in vivo studies, the antibody cocktail was found to neutralize rabies virus isolates (CVS11, Mexican (2004), Thai (2006), Indian (2008) canine variants and Texas Fox 393 rabies virus). In still another in vivo study, the cocktail was also found to neutralize rabies virus isolates from Dog, Canine, Human, and Bovine sources isolated from southern parts of India.

TwinrabTM – Bridging the unmet needs

  • Twinrab™ is a novel drug for rabies post-exposure prophylaxis (PEP), approved by DCGI
  • Twinrab™ received orphan drug designation from US FDA in May 2019
  • Twinrab™ is World's First Novel Cocktail of 2 mAbs binding to two distinct epitopes, Docaravimab: Site I or III and Miromavimab: Site II
  • Cell lines in Twinrab™ have been sourced from WHO collaborating centres
  • Twinrab™ ensures more protective titre at the site of bite
  • Twinrab™ neutralizes a wide variety of viruses
  • There is no risk of zoonotic infection
  • There is no skin sensitivity test required
  • Twinrab™ has reduced amount of proteins and high purity that ensures less adverse events

Therapeutic indication

TwinrabTM is indicated for post exposure prophylaxis in individuals with suspected rabies exposure. Twinrab™ must always be used in combination with Rabies vaccine as part of post exposure prophylaxis in line with the recommendation of World Health Organization (WHO).

Dose and Mode of Administration

The recommended dose of TwinrabTM is 40 IU per kg of body weight. TwinrabTM is administered through infiltration around the wounds / scratches and by intramuscular injection.The entire Twinrab™ dose, or as much as anatomically possible (avoiding possible compartment syndrome), should be infiltrated carefully into or as close as possible to the wound(s) or exposure sites.

References:

VACCINES

Zydus state of art vaccine manufacturing facilities are located at two different locations ( Moraiya and Changodar) in Ahmedabad. The vaccine facility located at Changodar is engaged in development and manufacturing of various vaccine products .The vaccine facility located at Moriaya site is engaged in manufacturing of Rabies vaccine (Human) and had received WHO pre-qualification and registered Rabies vaccine (Human) in different countries for export supplies.

Zydus had developed and received Marketing Authorization for various vaccine products like Rabies Vaccine (Human), Typhoid polysaccharide vaccine, Typhoid Vi conjugate vaccine, Inactivated Influenza Vaccine (Tetravalent & Trivalent), Measles containing live attenuated vaccines (Measles vaccine Measles & Rubella vaccine, Measles, Mumps and Rubella vaccine), Varicella vaccine and other combination vaccine like Td vaccine and Pentavalent vaccine. etc. Zydus has indigenously developed, manufactured and launched India's first Tetravalent Inactivated Influenza vaccine- VaxiFlu TM – 4.

During COVID pandemic, Zydus also developed and launched the World’s 1st and only human plasmid DNA vaccine against SARS-CoV-2 under brand name ZyCoV-D and in course also established the plasmid DNA Vaccine platform in the country.

Zydus has a rich pipeline of new vaccine products like Recombinant Hepatitis E, Inactivated Hepatitis A, Human papillomavirus (rDNA), Bivalent Typhoid and Paratyphoid A vaccine, Inactivated Chikungunya vaccine , Recombinant Varicella Vaccine with an aim to cater to the requirements of both India and export markets.



S.no Name of Vaccine Development Phase
1 Recombinant Hepatitis E Vaccine (Adsorbed) In Phase II Clinical trial
2 Inactivated Hepatitis A Vaccine (Adsorbed) Phase I completed
3 Measles, Mumps, Rubella and Varicella Vaccine (Live Attenuated ), (Freeze Dried) Phase I completed
4 Bivalent Typhoid and Paratyphoid A Conjugate vaccine Phase I to be initiated
5 Inactivated Chikungunya Vaccine (Adsorbed) PCT to be initiated
6 Human papillomavirus vaccine (rDNA), Nonavalent PCT to be initiated
7 Recombinant Varicella Vaccine Product under development

Zydus acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Government of India for funding the development, ICMR-National Institute of Virology, Pune for conduct of NHP Challenge study and PharmaJet Inc., Golden, CO, USA for providing PharmaJet® Tropis® Needle-Free Injection System (NFIS) for vaccine delivery. We also thank all the researchers, clinical trial investigators, volunteers and regulatory agencies including the office of the Drug Controller General of India (DCGI) who supported us in the development of ZyCoV-D.

SCIENTIFIC ACTIVITIES

Scientific Activities

A global knowledge sharing forum on innovation - The Ramanbhai Foundation International Research Symposium

The Ramanbhai Foundation International Symposium is a biannual series of symposia devoted to the discussion of new trends in the pharmaceutical industry with a view to promoting scientific excellence in drug discovery and development.

Ramanbhai Foundation is named after a pathfinder, Late Mr. Ramanbhai B. Patel, who had dedicated his life to the quest of knowledge, as an academician, entrepreneur and a research scientist. He believed that new paths would surely open up if one has the creative will to discover it.

For more than a decade, the Ramanbhai Foundation (RBF) international symposium has been bringing together experts from both the academia and industry across the world to share their insights on the latest developments in pharmaceutical research. Internationally acclaimed researchers converge to address the various aspects related to New Drug Discovery - with a focus on diabetes, cardiometabolic diseases, NASH, inflammation and infectious diseases. The keynote addresses over the past few years have been delivered by the Nobel Laureates and Research Scientists of international acclaim. The symposium provides an insight into various aspects of drug discovery had an eminent panel of speakers and nearly 500 delegates from India and abroad participated in the symposium.

To know more about the RBF Symposium and/or to participate, please visit www.rbfsymposium.net

Collaborate

COLLABORATE

Zydus is constantly exploring opportunities in pharma research under these specific categories:

  • Collaborative research and development
  • In-licensing of technologies/NMEs
  • Out-licensing/co-development of Zydus’ drug candidates

If you wish to partner with us, you may reach out to -
Business Development
Zydus Research Centre
Sarkhej-Bavla N.H. No. 8A
Moraiya, Ahmedabad – 382210
Gujarat, India.

Phone: +91-2717-665555
Fax: +91-2717-665353