Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-05-20T18:15:48+05:30 | Updated On 20 May 2025 6:15 PM IST

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New Delhi: Granting approval for conducting a bioequivalence (BE) study of Aprepitant powder for Oral Suspension 125 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined to the drug maker Zydus Lifesciences that the decision on the Phase III clinical trial may be taken after review of the bioequivalence (BE) study result.

This came after Zydus Lifesciences presented the proposal for a grant of permission to manufacture and market Aprepitant powder for Oral Suspension 125 mg along with BE protocol and justification for a clinical trial (CT) study waiver.

The firm informed that the Aprepitant powder for Oral Suspension 125 mg is already approved in the USA, EU, and UK, and Aprepitant capsules 40mg/80mg/125mg are already approved in India.

Aprepitant is a substance P/neurokinin 1 receptor antagonist used to treat nausea and vomiting caused by chemotherapy and surgery.

Aprepitant, an antiemetic, is a substance P/neurokinin 1 (NK1) receptor antagonist that, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors.

At the recent SEC meeting for oncology, the expert panel reviewed the proposal for grant of permission to manufacture and market Aprepitant powder for oral suspension 125 mg along with BE protocol and justification for CT study waiver.

After detailed deliberation, the committee recommended granting permission to conduct the BE study as per the protocol presented by the firm.

Accordingly, the expert panel suggested that the firm should submit the BE study report to CDSCO for further review by the committee.

In addition to the above, the expert panel stated that a decision on the Phase III clinical trial may be taken after review of the BE study result.

Also Read: Pfizer Gets CDSCO Panel Nod To study Anti-cancer Drug Disitamab vedotin

aprepitantbioequivalence studycdscozydus lifeciencesphase III trial

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751