Tracers / [177Lu]Lu-DOTATATE
[177Lu]Lu-DOTATATE
Also written as 177Lu-DOTA-TATE; [177Lu]Lu-DOTA-TATE; [177Lu]Lu-DOTATATE; [Lu-177]Lu-DOTATATE; DOTA-TATE; lutetium (177Lu) oxodotreotide
- Radionuclide
- Lu-177 t½ 9585 min
- Modality
- Therapy
- Production route
- —
- Stage
- approved (FDA-approved)
- Syntheses indexed
- 77
What it is
- Compound class
- DOTA-conjugated somatostatin analogue (radiolabelled peptide, octreotate)
- Target / mechanism
- Targets somatostatin receptor subtype 2 (SSTR2) PMID 39142827
- Clinical application
- Peptide receptor radionuclide therapy (PRRT) for somatostatin receptor-positive tumours, including neuroendocrine tumours and meningiomas PMID 40177560
- Theranostic pair
- <a href="/tracers/ga68-dotatate/">ga68-dotatate</a>
Regulatory status
- FDA
- —
- EMA (centralised)
- —
- Other approvals
- —
- Brand names
- —
Clinical use
- Typical injected activity
- —
- Uptake time
- —
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | — | — | DOTA-TATE ABX | 27090254 2016 EJNMMI Res 177Lu-radiolabelling was performed using the cassette-based ModularLab PharmTracer® synthesizer (EZAG, Berlin, Germany) |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | 80% | 99.8 ± 0.05% (ITLC); 97.3 ± 1.5% (HPLC) | DOTA-(Tyr3)-octreotate AUSPEP | 27408890 2015 Asia Ocean J Nucl Med Biol Eckert & Ziegler Eurotope’s Modular-Lab Pharm Tracer® automated synthesis system — an estimate of 80% synthesis yield |
| Manual synthesis | — | — | — | — | DOTATATE Bachem, Bubendorf, Switzerland | 42518020 2026 EJNMMI Res [177Lu]Lu-DOTATATE was radiolabelled as previously described by Lundsten et al. [28], using the same conditions as mentioned above. |
| Kit-based preparation Novartis | — | — | — | — | — | 42514966 2026 Pharmaceutics 177Lu-DOTATATE (Lutathera®, Novartis, Basel, Switzerland) |
| — | — | — | — | — | — | 42454478 2026 Endocr Relat Cancer |
| — | — | — | — | — | — | 42198448 2026 Pharmaceuticals (Basel) |
| — | — | — | — | — | — | 42177732 2026 EJNMMI Phys |
| — | — | — | — | — | — | 42149369 2026 Ann Nucl Med |
| — | — | — | — | — | — | 42141279 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41937276 2026 Med Phys |
| — | — | — | — | — | — | 41887730 2026 J Nucl Med |
| — | — | — | — | — | — | 41806239 2026 Clin Transl Oncol |
| — | — | — | — | — | — | 41798196 2026 Front Endocrinol (Lausanne) |
| Kit-based preparation | — | — | — | — | DOTATATE (octreotate) | 41710577 2026 Drug Des Devel Ther The peptide is conjugated via a DOTA chelator, which securely coordinates the β-emitter radioactive isotope lutetium-177 |
| — | — | — | — | — | — | 41693498 2026 Nucl Med Commun |
| Kit-based preparation | — | — | — | — | — | 41610875 2026 Nuklearmedizin In-house preparations (using GMP-grade kits and in-house radiolabelling) |
| — | — | — | — | — | DOTATATE | 41356201 2026 Theranostics |
| — | — | — | — | — | — | 41355961 2026 Theranostics |
| — | — | — | — | — | — | 41342316 2026 Chembiochem |
| — | — | — | — | — | — | 41117982 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41083371 2026 Endocr J |
| — | — | — | — | — | — | 40970962 2026 Eur J Nucl Med Mol Imaging |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | — | 98 ± 3% no | 95.2 ± 1.3% (0h HPLC) | DOTA-TATE Huayi | 40696084 2025 EJNMMI Radiopharm Chem This process was automated using an iPHASE MultiSyn radiochemistry module with sterile kits affording sterile and apyrogenic 177Lu-labeled radiopharmaceuticals in non-decay corrected yields > 95%. — The yield for this radiopharmaceutical was 98 ± 3%. |
| — | — | — | — | — | — | 40634058 2025 Endocr J |
| — | — | — | — | — | — | 40598690 2025 Cancer Imaging |
| — | — | — | — | — | — | 40455253 2025 Eur J Nucl Med Mol Imaging |
| Kit-based preparation Advanced Accelerator Applications | — | — | — | — | — | 40361351 2025 Cancers (Basel) Lutathera® was obtained commercially from Advanced Accelerator Applications, a Novartis Company (Colleretto Giacosa, Italy). |
| — | — | — | — | — | — | 40302310 2025 J Neuroendocrinol |
| — | — | — | — | — | — | 40186742 2025 Ann Nucl Med |
| Manual synthesis | — | — | — | — | DOTATATE | 40177560 2025 Acta Pharm Sin B 177Lu-DOTATATE and 177Lu-EB-TATE were radiolabeled using the same method. |
| Manual synthesis | — | — | — | more than 95% | DOTATATE AUSPEP | 40147849 2025 J Nucl Med Radiolabeling of the DOTA compounds was done at 85°C for 25 min, using ascorbic acid buffer and no-carrier-added [177Lu]LuCl3 |
| — | — | — | — | — | — | 39351526 2024 Front Endocrinol (Lausanne) |
| Manual synthesis | — | HPLC | — | >96 % | DOTA-TATE Bachem, Bubendorf, Switzerland | 39310112 2024 Theranostics Radiolabeling with lutetium‑177 and copper‑67 was performed in sodium ascorbate buffer (0.15 mol/L, pH 4.8) for 40 min, at 80 °C and 40 °C, respectively. |
| — | — | — | — | — | DOTATATE | 39142827 2024 J Nucl Med |
| Manual synthesis | — | none | — | >98% | DOTATATE Bachem, Bubendorf, Switzerland | 39046521 2024 Eur J Nucl Med Mol Imaging DOTA-LM3 (CSBio, Silicon Valley Menlo Park, California, United States) and DOTATATE (Bachem, Bubendorf, Switzerland) were labeled with terbium-161 or lutetium-177 at a molar activity of up to 100 MBq/nmol using standard labeling conditions as previously reported |
| — | — | — | — | — | — | 38929531 2024 Medicina (Kaunas) |
| — | — | — | — | — | — | 38324106 2024 Endocrine |
| — | — | — | — | — | — | 38250038 2024 Theranostics |
| — | — | — | above 97% | above 90% | DOTA-TATE Bachem, Bubendorf, Switzerland | 36145306 2022 Pharmaceuticals (Basel) |
| — | — | — | — | — | — | 35450421 2022 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 34475242 2021 J Nucl Med |
| — | — | — | — | — | — | 33916707 2021 Cancers (Basel) |
| — | — | — | — | — | — | 33037092 2020 J Nucl Med |
| — | — | — | — | — | — | 30854332 2019 Front Oncol |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | — | — | DOTA-TATE ABX | 27090254 2016 EJNMMI Res 177Lu-radiolabelling was performed using the cassette-based ModularLab PharmTracer® synthesizer (EZAG, Berlin, Germany) |
| — | — | — | 98% | — | DOTA-TATE | 40425733 2026 Nat Protoc |
| — | — | — | — | — | — | 41006727 2025 Med Oncol |
| — | — | — | — | more than 99% | DOTATATE | 26443981 2016 Nucl Med Commun novel, self-shielded modular radiosynthesis system for fully automated preparation of PET and therapeutic radiopharmaceuticals |
| — | — | — | >99% | >99% | — | 22149590 2012 Cancer Biother Radiopharm reprogramming and adaptation of a commercially available synthetic module (IBA molecular; Synthera®) allowed high yield, fully automated, in-house radiolabeling — (68)Ga-octreotate and (177)Lu-octreotate were synthesized, resulting in both radiochemical yield and radiochemical purity greater than 99%. |
| — | — | — | — | — | — | 42658097 2026 Health Phys |
| — | — | — | — | — | — | 42579511 2026 Endocr Relat Cancer |
| — | — | — | — | — | — | 42573792 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42555490 2026 Hell J Nucl Med |
| — | — | — | — | — | — | 42526976 2026 Clin Lab Med |
| — | — | — | — | — | — | 42517999 2026 Ann Nucl Med |
| — | — | — | — | — | — | 42472334 2026 Hell J Nucl Med |
| — | — | — | — | — | — | 42472319 2026 Hell J Nucl Med |
| — | — | — | — | — | — | 42333414 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42302403 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42234009 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42169550 2026 Nucl Med Commun |
| — | — | — | — | — | — | 42167802 2026 J Nucl Med |
| — | — | — | — | — | — | 42097922 2026 PET Clin |
| — | — | — | — | — | — | 41978352 2026 Nucl Med Commun |
| — | — | — | — | — | — | 41932368 2026 J Control Release |
| — | — | — | — | — | — | 41536178 2026 Nucl Med Commun |
| — | — | — | — | — | — | 41533312 2026 Jpn J Radiol |
| — | — | — | — | — | — | 41131958 2025 Nucl Med Rev Cent East Eur |
| — | — | — | — | — | — | 40227439 2025 Radiologie (Heidelb) |
| — | — | — | — | — | — | 32414949 2020 J Nucl Med |
| — | — | — | — | — | — | 32293704 2020 Endokrynol Pol |
| — | — | — | — | — | — | 28588150 2018 J Nucl Med |
| — | — | — | — | — | DOTATATE | 28450554 2017 J Nucl Med |
| — | — | — | — | — | — | 27890514 2017 Rev Esp Med Nucl Imagen Mol |
| — | — | — | — | — | — | 25771364 2016 Curr Radiopharm |
| — | — | — | — | — | — | 21993546 2012 Oncol Rep |
| — | — | — | — | — | — | 19601842 2009 Curr Pharm Des |
Need this precursor?We can point you to suppliers for [177Lu]Lu-DOTATATE, or handle the enquiry for you.
Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- no specific monograph
- USP monograph
- not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. No Lu-177 monograph — base set per Ph. Eur. 0125 + rule-based (see Ga-68 analogue monograph 3050 for the ligand method). Lu-177m content + metal impurities + molar activity + osmolality per rules.
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [177Lu]Lu-DOTATATE.
Get in touchNotes
Stage 8: Lutathera / [177Lu]Lu-DOTA-TATE. 2 corpus articles with Lu-177 (PMID 35966589, 35906092) were collapsed onto the Ga-68 anchor [68Ga]Ga-DOTATATE. Added as its own row. Theranostic hub: also paired (one-way) from cu64-dotatate, f18-fet-bag-toca -- ga68-dotatate (NETSPOT) is the FDA-approved companion diagnostic for Lu-177-DOTATATE (Lutathera); the other two are additional diagnostics paired with the same therapeutic in the literature. [stage 19] Compound class inferred from precursor name (not stated outright) -- PMID 27408890: 'DOTATATE, or DOTA-(Tyr3)-octreotate (where DOTA = 1,4,7,10-tetraazacyclododecane– 1,4,7, 10-tetraacetic acid) was obtained from Auspep (Melbourne, Australia)'. Stage set/updated at stage 23 from PMID 40696084: 'Lutetium-177 (177Lu) theranostics have revolutionized personalized cancer treatment, particularly with FDA-approved therapies like [177Lu]Lu-DOTA-TATE for neuroendocrine tumors and [177Lu]Lu-PSMA for prostate cancer.'.