Cipla gets CDSCO Panel nod for Phase-III CT of Inhaled Itraconazole dry powder for inhalation 10 mg capsules
New Delhi: Accepting the phase II clinical trial results of inhaled itraconazole dry powder for inhalation 10 mg capsules (PUR1900) presented by the pharmaceutical major Cipla, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has agreed to the firm’s proposal to proceed with the 40mg dose of inhaled itraconazole dry powder for inhalation 10 mg capsules (PUR 1900) in phase III clinical trial.
This came after the drug major Cipla presented the Phase II clinical trial report before the committee.
PUR1900 is a dry powder formulation of itraconazole, designed for inhalation delivery. It is primarily being developed to treat fungal infections—specifically Aspergillus infections in patients with cystic fibrosis (CF) and potentially other respiratory diseases.
Itraconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection. Itraconazole acts by inhibiting the fungal cytochrome P-450-dependent enzyme lanosterol 14-α-demethylase. When this enzyme is inhibited, it blocks the conversion of lanosterol to ergosterol, which disrupts fungal cell membrane synthesis.
Itraconazole is used to treat certain types of fungal infections. It stops fungi from growing. Common side effects include nausea, vomiting, diarrhea, constipation, and headache. Serious side effects can include liver damage and nerve problems.
At the recent SEC meeting for pulmonary held on 11th March 2025, the expert panel reviewed the Phase II clinical trial report presented by Cipla.
After detailed deliberation, the committee accepted the phase II clinical trial results and agreed to the firm’s proposal to proceed with the 40mg dose of inhaled itraconazole dry powder for inhalation of 10 mg capsules (PUR 1900) in the phase III clinical trial.
Additionally, the expert panel suggested that the firm should submit the Phase III protocol to CDSCO for taking further necessary action.
