DCGI grants permission for Phase-I clinical trial of Levormeloxifene
Bureau chief R L Pandey
Lucknow।The Drugs Controller General of India (DCGI) has granted permission to Cipla to conduct a Phase-I clinical trial of Levormeoxifene.
The investigational drug is being developed as a joint collaboration between Cipla and CSIR-Central Drug Research Institute (CSIR-CDRI), Lucknow as an oral, non-hormonal contraceptive.
The permission granted by DGCI is based on the recommendations of the Subject Expert Committee (SEC) which carefully reviewed the data generated by CSIR-CDRI and Cipla.
Ormeloxifene, is a non-hormonal oral
contraceptive pill developed by CSIR-Central Drug Research Institute (CSIR-CDRI). It has been in the market since the 1990s under the brand name “Saheli” and is included in the National Family Planning program of the Government of India under the brand name “Chhaya”.
Ormeloxifene is a mixture of two enantiomers, i.e. compounds with the same chemical composition but mirror image 3-dimensional structures. In preclinical studies, the efficacy of Ormeloxifene was found to be driven by the levo form. Therefore, CSIR-CDRI and Cipla Ltd entered into an agreement to develop Levormeloxifene for contraceptive use.
Dr. Radha Rangarajan, Director CSIR-CDRI said, “The rationale for developing the pure enantiomer is to reduce the overall chemical burden for the user, in this case women of reproductive age”.
Cipla and CSIR-CDRI have a longstanding partnership in the development of affordable drugs, both within India and globally.