Submit Phase I/Phase II clinical trial data: CDSCO Panel Tells Mankind on Dydrogesterone Injection 5mg/ml

Dydrogesterone is a progestin, or a synthetic progestogen, and hence is an agonist of the progesterone receptor, the biological target of progestogens like progesterone. The medication is an atypical progestogen and does not inhibit ovulation.

Dydrogesterone is used in female infertility, pain during menstruation, Premenstrual syndrome (PMS) and endometriosis. Dydrogesterone contains progestin (female hormone) that plays a major role in regulating the menstrual cycles in females. It initiates the normal, regular growth as well as shedding of the womb lining.

At the recent SEC meeting for Reproductive, the expert panel reviewed the proposal for grant of permission to manufacture and market dydrogesterone injection 5 mg/mL (Additional Dosage Form) along with Phase-III clinical trial protocol before the committee.

After detailed deliberation, the committee opined that the firm should submit Phase-I/Phase-II clinical trial data, including PK/PD study data to establish a safe and effective dose in IM (intramuscular) route, to CDSCO for further review by the committee.

Further, the expert panel suggested that animal toxicity data shall be carried out in accordance with para 2 of the second schedule of the New Drugs and Clinical Trials Rules (ND and CT).

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