Key Highlights:
- Optimus Pharma, a Sekhmet Pharmaventures subsidiary, has become the first company in India to receive DCGI permission to manufacture and market Tapinarof Cream 1% w/w and its bulk drug for plaque psoriasis in adults. Tapinarof is a non-steroidal aryl hydrocarbon receptor agonist.
- The approval is backed by an Indian clinical study of 213 patients with moderate-to-severe plaque psoriasis, where Tapinarof demonstrated statistically significant superiority over placebo in PGA success at Week 12. Significant improvements were also seen in PASI ≥50, BSA involvement, itching, psoriasis symptoms and DLQI, while higher PASI responses showed numerical improvement.
- Tapinarof was well tolerated, with no immunogenicity concerns reported. Optimus will manufacture both the bulk drug and finished formulation in-house at cGMP-compliant facilities inspected by the US FDA and European regulators, enabling end-to-end control from drug substance to finished product and supporting an early launch through strategic partners.
Implications:
Optimus Pharma’s DCGI approval for Tapinarof Cream 1% gives India its first locally manufactured, non‑steroidal topical for adult plaque psoriasis, offering dermatologists a steroid‑sparing option that showed significant improvements in PGA success, PASI ≥50, itch and quality of life in an Indian Phase III study. With end‑to‑end in‑house manufacturing and no innovator presence in India, Optimus can move quickly through partners to capture early share in a large, under‑served psoriasis market, potentially shifting prescribing away from long‑term topical steroids and positioning Tapinarof as a first‑line or maintenance therapy for moderate disease.
Source: ExpressPharma
