India Pharma Outlook Team | Monday, 21 July 2025
Sun Pharma announced that its monoclonal antibody drug ILUMYA (tildrakizumab 100 mg) has demonstrated favorable results in two Phase 3 clinical trials in active psoriatic arthritis (PsA), putting it on the path to possible U.S. regulatory filings.
The INSPIRE-1 and INSPIRE-2 trials, both at late-stage, evaluated ILUMYA's safety and efficacy for 24 weeks. Both trials attained statistically significant ACR20 response rates—a primary marker for the effectiveness of arthritis therapies—vs. placebo at Week 24.
INSPIRE-1 enrolled patients with previous anti-TNF exposure, and INSPIRE-2 enrolled naïve anti-TNF patients. There were more than 800 adult patients from US, European, and Asian clinical sites. ILUMYA was given at baseline and every 12 weeks without an induction dose.
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Sun Pharma said the safety outcome of both studies were in line with ILUMYA's known profile in plaque psoriasis and that no new safety observations were seen. The drug is still investigational in psoriatic arthritis and not yet approved by regulatory agencies for this use.
ILUMYA is currently launched in the US and other countries for the treatment of adults with moderate-to-severe plaque psoriasis. It works by inhibiting the p19 subunit of interleukin-23 (IL-23), a central inflammatory pathway associated with chronic autoimmune conditions.
Additional in-depth data from INSPIRE trials will be shared at future medical congresses and be submitted for journal publication.
With more than 100 markets worldwide, Sun Pharma is actively developing its specialty pipeline in dermatology, ophthalmology, and onco-dermatology, positioning itself as India's largest pharma company and a global leader in the generics business.
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