Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Lutetium Lu 177 dotatate (Lutathera): what the evidence says
At a glance
What it is: a somatostatin-like cyclic peptide carrying radioactive lutetium-177, which delivers radiation to tumor cells with somatostatin receptors. Approved Jan 2018; now labeled for adults and children 12+. R1, R2
What the evidence says: Human in NETTER-1 (229 patients with advanced midgut NETs), it gave much longer progression-free survival and an 18% vs 3% response rate compared with high-dose octreotide; an interim analysis suggested longer survival. R3
Biggest risks: radiation exposure, bone-marrow suppression, later MDS or leukemia, and kidney toxicity. R2
Rating
| Human Human evidence | Strong: NETTER-1 RCT (n = 229) R3 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R4, R5, R6 · not named by WADA R7 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Somatostatin receptor-positive GEP-NETs: Strong (phase 3 RCT)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: one large randomized trial in midgut tumors; the label covers broader GEP-NETs. Hospital nuclear-medicine use only.
What is it?
Related pages: octreotide, lanreotide, pasireotide.
Does it work?
- Human Response 18% vs 3%; interim deaths 14 vs 26. R3
Is it safe?
- Human Grade 3/4 low blood counts in under 10%. R3
- Label: secondary MDS/leukemia, kidney toxicity. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription (radiopharmaceutical). R1
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R4, R5, R6
- Sport: not named on WADA's 2026 Prohibited List. R7
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| NETTER-1 2017 | 229 midgut NET patients | IV, 4 infusions | 7.4 GBq every 8 weeks | Until progression | PFS longer; response 18% vs 3% | PMID 28076709 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Lutathera (lutetium Lu 177 dotatate), application NDA208700 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA208700
- R2 Lutathera prescribing information, label published Jan 15, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55
- R3 Strosberg J, et al. N Engl J Med. 2017. PMID 28076709
- R4 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R5 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R6 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Lutetium Lu 177 dotatate (Lutathera). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).