CDSCO Panel Approves Cipla's Levormeloxifene Study Amendment, Mandates Transvaginal Sonography

New Delhi: The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has recommended approval for an amendment to drug major Cipla's ongoing Phase I clinical study of Levormeloxifene fumarate tablets (15 mg), with added safety requirements.

However, this nod is subject to the condition that the firm should include a transvaginal sonography test for the uterus and both ovaries at the end of the study period.

This came after the pharmaceutical major Cipla presented the amendment in the phase I study vide protocol no. 0116-01-23, Version 05 dated 19.02.2025, before the committee.

This is a randomised, single-dose, oral, open-label, two-treatment, parallel pharmacokinetic study between the test product, Levormeloxifene 15 mg tablet (Cipla Ltd., India) and the reference product, Saheli (Ormeloxifene also known as Centchroman) 30 mg tablet (Manufactured by HLL Lifecare Ltd, India) administered in healthy adult female subjects under fasting conditions.

Levormeloxifene (fumarate) is a stable salt form of Levormeloxifene. Levormeloxifene (fumarate) is an estrogen receptor modulator that plays an important role in the prevention of postmenopausal bone loss.

At its recent meeting on Investigational New Drugs, the Subject Expert Committee (SEC) reviewed Cipla’s proposed amendment to the Phase I study of Levormeloxifene fumarate tablets (15 mg), submitted under protocol no. 0116-01-23, Version 05 dated February 19, 2025.

After detailed deliberation, the committee recommended for approval of the protocol amendment as presented by the firm, subject to the condition that the firm should include a transvaginal sonography test for the uterus and both ovaries at the end of the study period.

In addition, the expert panel suggested that the firm should submit a revised protocol to CDSCO for further evaluation.