Optimus Pharma, a leading Indian pharmaceutical manufacturer and subsidiary of Sekhmet Pharmaventures, announced that it has received regulatory marketing approval for Tapinarof cream, an innovative non-steroidal topical treatment for adult plaque psoriasis.
The regulatory clearance covers both the finished formulation and the active pharmaceutical ingredient (API), both of which will be produced in-house at Optimus Pharma’s cGMP-compliant manufacturing facilities.
Approval was granted following successful clinical trial outcomes in India. In a local study involving 213 patients, Tapinarof cream demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success after 12 weeks of treatment. Additionally, the trial demonstrated clear numerical improvements across secondary endpoints, including Body Surface Area (BSA) involvement, the Peak Pruritus Numeric Rating Scale (PP-NRS), and Psoriasis Symptom Diary (PSD) scores. As part of the regulatory mandate, Optimus Pharma will initiate a post-marketing safety study within three months.
Tapinarof acts as a novel aryl hydrocarbon receptor (AhR) agonist, providing patients with a targeted, non-steroidal option for long-term management of chronic skin conditions. Internationally, the molecule is marketed under the brand name Vtama.
“The approval for Tapinarof is a significant milestone for Sekhmet and reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality,” said Sumit Kumar, Chief Commercial Officer at Sekhmet Pharmaventures.
With this approval, Optimus Pharma reinforces its position in advanced dermatology, strengthening India’s domestic supply chain for high-quality, vertically integrated therapies.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
