REPOSITIONING INTELLIGENCE — EVIDENCE REPORT
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Generated: Nov 12, 2026, 11:53 PM UTC

DISCLAIMER: This report is for research and informational use only.
It is NOT medical advice, diagnosis, or treatment guidance.

DRUG–DISEASE PAIRING
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Drug:     Sirolimus (Rapamycin)
Disease:  Tuberous Sclerosis Complex
Target:   Mechanistic target of rapamycin

EVIDENCE GRADE: Approved
Confidence Score: 93%
Evidence Level: Level 1 (RCT + regulatory approval)
Trial Phase: Phase III

MECHANISM
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mTOR inhibition reduces hamartoma growth in TSC1/TSC2-deficient cells.

OUTCOMES
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Reduced SEGA volume and stabilized renal angiomyolipoma.

AI SUMMARY (generated March 15, 2026)
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Everolimus and sirolimus have FDA-approved TSC indications based on Phase III trials demonstrating tumor volume reduction. Mechanistically grounded in TSC–mTOR pathway biology.

KNOWN RISKS
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• Immunosuppression
• Hyperlipidemia
• Mouth ulcers
• Impaired wound healing

CITATIONS
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[PUBMED] 19949031: Sirolimus for angiomyolipoma in tuberous sclerosis
  https://pubmed.ncbi.nlm.nih.gov/19949031/

[CLINICALTRIALS] NCT00457808: Everolimus for SEGA in TSC
  https://clinicaltrials.gov/study/NCT00457808

[FDA] 021560: Rapamune (sirolimus)
  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021560

PUBMED IDs: 19949031
CLINICAL TRIAL IDs: NCT00457808

LAST VERIFIED: June 18, 2026
LAST UPDATED:  June 18, 2026
REVIEW STAGE:  published

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Repositioning Intelligence Platform · Research Mode