Rani Takes Next Step As Oral Ustekinumab Biosimilar Enters The Clinic

Oral Biologics Specialist Using Celltrion’s CT-P43 Candidate Under License

As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

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Rani Therapeutics says that it is “one step closer to our goal of making oral biologics a reality for patients with autoimmune diseases,” after initiating a Phase I clinical trial to evaluate the safety and tolerability of its proposed RT-111 orally administered ustekinumab biosimilar.

With topline results from the study expected early in the first quarter of 2024, Rani’s CEO Talat Imran welcomed advancement for RT-111, which is contained in

Key takeaways:
  • Rani Therapeutics has initiated a Phase I clinical trial to evaluate the safety and tolerability of its proposed RT-111 orally administered ustekinumab biosimilar, using Celltrion’s CT-P43 ustekinumab product.

  • The first subject has been administered RT-111 in the single-center, open-label Phase I study, which is being conducted in Australia

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