Tesamorelin was developed under the brand name Egrifta and received FDA approval for reducing excess visceral fat in HIV-associated lipodystrophy, making it one of the few GHRH analogs with both clinical trial data and regulatory approval behind it
First, clinicians should acknowledge the origin of the concern
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
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