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pp-091

Injection

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
EU GMP
Comments
Indication: Fecal urge incontinence from weakened external anal sphincter, often post-childbirth, causing sudden uncontrollable bowel movements; for patients not controlled by conservative or device therapies. Clinical stage: Multiple Phase I/II trials with long-term data; late-phase study in Japan; EU Phase III in preparation; approvals targeted for Japan, EU, and U.S. Modality: Autologous cell therapy. Mechanism / Target: Local injection of expanded skeletal muscle cells to regenerate sphincter function. Route / form: Local injection into the external anal sphincter. Differentiation: First regenerative therapy targeting the underlying cause of fecal urge incontinence; addresses major unmet need in a population underserved by medications, biofeedback, neuromodulation, or artificial sphincter implantation; supported by extensive multicenter clinical data from 19 clinics across eight European countries with sustained functional improvement demonstrated in early-phase trials.
Manufacturer #38642

A clinical-stage biotechnology firm developing regenerative cell therapies to treat fecal and urinary incontinence by restoring sphincter muscle function rather than just managing symptoms. It advances proprietary autologous cell therapy programs through multinational Phase III clinical development with global strategic aims. The organization combines R&D, manufacturing and clinical expertise to address high unmet needs.

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