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Kiora licenses Senju's oral calpain inhibitor KIO-401 for retinal artery occlusion, seeks FDA meeting

🇺🇸 Kiora Pharmaceuticals Inc (KPRX) · Thu 12 Nov 2026

The US ophthalmology developer has acquired rights outside Asia to mitucapistat and has asked the FDA for a pre-IND meeting and orphan drug designation.

Kiora Pharmaceuticals said in its third-quarter 2026 update, dated 12 November, that it has licensed exclusive rights outside Asia to KIO-401 (mitucapistat) from Senju Pharmaceutical. The oral calpain inhibitor is being developed for central retinal artery occlusion (CRAO).

On the regulatory side, the company has asked the US Food and Drug Administration for a Type B pre-IND meeting and for orphan drug designation. It is also planning a single multinational Phase 3 registration trial. As general context, orphan designation in the US is intended to support development of treatments for rare diseases, and a pre-IND meeting lets sponsors discuss development plans with the agency before filing an investigational new drug application.

Kiora reported cash of about $16.3 million and a net loss of roughly $1.7 million for the third quarter. The company said its Phase 2 ABACUS-2 trial of KIO-301 is ongoing, and that it has licensed KIO-301 in South Korea to Chong Kun Dang. It has also discontinued investment in KIO-104.

The full source text was not available, so details such as financial terms of the Senju deal, the trial design and the timing of the FDA meeting are not covered here.

What it means for your team

  • Regulatory teams tracking rare retinal disease should note the planned single multinational Phase 3 registration trial for CRAO and the pending orphan designation request.
  • The outcome of the Type B pre-IND meeting will indicate how the FDA views the proposed development path for KIO-401.
  • Market-access and licensing teams can note the split of rights, with Kiora holding KIO-401 outside Asia and KIO-301 licensed to Chong Kun Dang in South Korea.

Company's press release (SEC filing): Kiora Pharmaceuticals Inc ↗

Article written by VigiEye from the official source (Kiora Pharmaceuticals Inc). Claims are the company's own. AI-assisted; check the source before acting.

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