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Based on the current stage of clinical development and estimated trial completion dates registered on ClinicalTrials.gov, a realistic earliest possible timeline might be considered as follows: 20252026: Completion of key phase 3 TRIUMPH trial data 20262027: Potential regulatory submission to the MHRA (and FDA/EMA in parallel) 20272028: Possible MHRA marketing authorisation, subject to satisfactory review 2028 onwards: NICE technology appraisal and potential NHS commissioning decision These timelines are speculative and depend on multiple variables, including trial outcomes, the completeness of the regulatory submission, MHRA review timelines, and NICE deliberations

While the medication does not directly cause gastrointestinal bleeding, its effects on bowel function may indirectly contribute to conditions like hemorrhoids or anal fissures that produce rectal bleeding