Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Webinars
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • CDSCO (Central Drugs Standard Control Organisation) News
  • AstraZeneca Gets SEC...

AstraZeneca Gets SEC Approval to Conduct Phase IV Trial of Hyperkalemia Drug Sodium Zirconium Cyclosilicate

Susmita RoyWritten by Susmita Roy Published On 2025-09-11T13:58:41+05:30  |  Updated On 11 Sept 2025 1:58 PM IST
AstraZeneca Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO), has granted approval to the drug major AstraZeneca Pharma India to conduct a Phase-IV Clinical trial of Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g, used to treat hyperkalemia.

This came after AstraZeneca Pharma India presented the Phase IV clinical trial protocol of the drug Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g (Protocol no. D9480L00025, Ver. 1.0 dated 30.05.2025), before the committee.

The firm presented the study objective, study design, inclusion and exclusion criteria, risk assessment and mitigation strategy, dose modification criteria, management and reporting of adverse event (AE), safety evaluation, statistical analysis methodology, and sample size to be enrolled in the study, etc.

Also Read:Mankind Pharma wins CDSCO nod to start Phase 1 trials of Autoimmune drug candidate

Sodium zirconium cyclosilicate is approved as the trade product Lokelma, developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent.

Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death.

Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.

At the recent SEC meeting, the expert panel reviewed the Phase IV clinical trial protocol of the drug Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g (Protocol no. D9480L00025, Ver. 1.0 dated 30.05.2025).

After detailed deliberation, the committee recommended the grant of permission to conduct a Phase-IV Clinical trial as per the protocol presented by the firm.

Also Read:Novo Nordisk Gets CDSCO Panel Nod for Rybelsus Label Update, Aligned with EMA
cdscoastrazenecaastrazeneca indiaSodium zirconium cyclosilicate
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

    Show Full Article
    Next Story

    Editorial

    EASD 2025: First-Ever Guidelines Released to Address Diabetes Distress

    EASD 2025: First-Ever Guidelines Released to Address Diabetes Distress

    PRO-ACT Study Compares Topical Minoxidil 5% with PRCT vs Plain Minoxidil 5% in Androgenetic Alopecia-Combination Shows Superior Efficacy

    PRO-ACT Study Compares Topical Minoxidil 5% with PRCT vs Plain Minoxidil 5% in Androgenetic...

    DAa-ViNCI Study: Real-World Data shows Efficacy of Vildagliptin-  Dapagliflozin FDC among High-CV Risk T2D in Indian Cardiology  Settings

    DAa-ViNCI Study: Real-World Data shows Efficacy of Vildagliptin- Dapagliflozin FDC among High-CV...

    Indias Unique CV Risk Profile: How to Decode the Role of Aspirin?

    India's Unique CV Risk Profile: How to Decode the Role of Aspirin?

    Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

    Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest...

    View All

    Journal Club Today

    New Brain Research Uncovers How Music Triggers Movement, Emotion, and Connection

    New Brain Research Uncovers How Music Triggers Movement, Emotion, and Connection

    View All

    Health News Today

    Health Bulletin 22/October/2025

    Health Bulletin 22/October/2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok