Optimus Pharma gets DCGI permission for Tapinarof Cream 1% w/w

Optimus Pharma, a subsidiary of Sekhmet Pharmaventures, has become the first company in India to receive permission from the Drugs Controller General of India (DCGI) to manufacture and market Tapinarof Cream 1 per cent w/w and the tapinarof bulk drug.

Tapinarof Cream 1 per cent w/w is a non-steroidal topical treatment for plaque psoriasis in adults.

Psoriasis is a chronic, non-communicable skin condition that the World Health Organization estimates affects at least 100 million people worldwide. Indian studies place prevalence in the country between 0.44 and 2.8 percent, with plaque psoriasis the most common presentation. Many patients depend on long-term topical therapy, where options beyond corticosteroids have remained limited. Tapinarof, a topical aryl hydrocarbon receptor agonist, provides a non-steroidal option for the management of plaque psoriasis in adults.

Optimus’ clinical study in India enrolled 213 patients with moderate-to-severe plaque psoriasis. Tapinarof Cream 1 per cent w/w demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success at Week 12.

Significant improvements compared with placebo were also observed in the Psoriasis Area and Severity Index (PASI ≥50), percentage reduction in Body Surface Area (%BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS) and Psoriasis Symptom Diary (PSD) scores. Numerical improvements were observed in higher PASI response rates (PASI ≥75 and PASI ≥90). Additionally, significant improvements were seen in Dermatology Life Quality Index (DLQI) scores.

Tapinarof Cream 1 per cent w/w was well tolerated in Indian patients, and no immunogenicity concerns were identified during the study.

Tapinarof Cream 1% w/w and its bulk drug are manufactured at facilities operating cGMP-compliant quality systems. These facilities have undergone inspections by regulatory agencies including the US FDA and European authorities, and are designed to ensure product quality, reliability and patient safety through controls across manufacturing, testing and supply operations.

With both the bulk drug and the finished formulation produced in-house, Optimus maintains control across the end-to-end manufacturing journey, from drug substance to finished dosage form, supporting consistency, traceability and quality at every stage.

The approval reflects the company’s capabilities in the development and manufacture of complex and differentiated formulations, enabling early launch through its strategic partners and making products available to Indian patients.

Sumit Kumar, Chief Commercial Officer, Sekhmet Pharmaventures, said: “The approval for Tapinarof Cream 1 per cent w/w and its bulk drug is a significant milestone for Sekhmet and a testament to the strength of our R&D, regulatory, quality and manufacturing capabilities. The group is backed by more than 250 scientists, reinvests over 12 percent of revenue into R&D, and has filed more than 300 patents and secured over 170 grants. Being the first company in India to receive this permission reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality and compliance.”

Optimus’ Tapinarof Cream 1 per cent w/w is a prescription-based drug. Patients are advised to consult their doctors for more details.

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