Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Thyroid Cancer (Well-Differentiated) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Thyroid Cancer (Well-Differentiated). ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Thyroid Cancer (Well-Differentiated): 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06482086). The largest enrolment is 154 participants (NCT01552434). Registration activity spans 2006 to 2021. No published literature item is linked to Sirolimus and Thyroid Cancer (Well-Differentiated) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Thyroid Cancer ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not applicable — surgical resection is standard; papillary microcarcinoma (<1 cm, low-risk): active surveillance achieves 99.8%+ cancer-specific survival at 10 years without immediate surgery in Japanese cohorts.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 44.0 (trials 24.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01270321 | Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer 2010 | completed | Phase 2 | 42 |
| NCT01025453 | Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer 2009 | completed | Phase 2 | 37 |
| NCT01164176 | Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer 2010 | completed | Phase 2 | 40 |
| NCT06482086 | Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer 2021 | recruiting | Phase 2 | 75 |
| NCT03099356 | Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer 2017 | recruiting | Phase 2 | 22 |
| NCT03139747 | UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone 2017 | suspended | Phase 2 | 5 |
| NCT00375245 | Rapamycin With Grapefruit Juice for Advanced Malignancies 2006 | completed | Phase 1 | 41 |
| NCT01552434 | Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease 2012 | terminated | Phase 1 | 154 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Thyroid Cancer (Well-Differentiated)?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Thyroid Cancer (Well-Differentiated) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Thyroid Cancer (Well-Differentiated). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Thyroid Cancer (Well-Differentiated)?
ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Thyroid Cancer (Well-Differentiated): 2 are currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06482086). The largest enrolment is 154 participants (NCT01552434). Registration activity spans 2006 to 2021.
What does the evidence show for Sirolimus in Thyroid Cancer (Well-Differentiated)?
Sirolimus has 4 completed registered trials for Thyroid Cancer (Well-Differentiated) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.