Drug Type Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals |
Synonyms 177-Lutetium-PSMA-617(RadioMedix, Inc.), [Lu-177] vipivotide tetraxetan, Lu-177-PSMA-617 Lutetium-177-PSMA-617 + [13] |
Target |
Action inhibitors |
Mechanism PSMA inhibitors(Prostate-specific membrane antigen inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (23 Mar 2022), |
RegulationBreakthrough Therapy (United States), Priority Review (China), Orphan Drug (South Korea) |
Molecular FormulaC49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS Registry1703749-62-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic castration-resistant prostate cancer | Canada | 25 Aug 2022 | |
PSMA-Positive Castration-Resistant Prostatic Cancer | United States | 23 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic Prostate Carcinoma | Phase 3 | France | 12 Sep 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | United States | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | China | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Japan | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Argentina | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Australia | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Austria | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Belgium | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Brazil | 12 Mar 2024 | |
Oligometastatic Prostate Carcinoma | Phase 3 | Canada | 12 Mar 2024 |
Phase 2 | PSMA-Positive Castration-Resistant Prostatic Cancer PSMA-positive | 35 | owmofoghjj(ozotsdlamy) = izqrxmqpmz rtbbcecnnu (ogstcqhcgk ) View more | - | 10 Jul 2025 | ||
owmofoghjj(ozotsdlamy) = dndmavzyom rtbbcecnnu (ogstcqhcgk ) View more | |||||||
Phase 2 | Castration-sensitive prostate cancer PSMA-expressing | 58 | jgsvbavcoa(cnyudeialm) = jedecfktag vnywgvonxr (xafkrlscqv ) View more | Positive | 30 May 2025 | ||
(Standard of Care (SoC) - Deferred ADT) | jgsvbavcoa(cnyudeialm) = pwgtsjgmkg vnywgvonxr (xafkrlscqv ) View more | ||||||
Not Applicable | - | 177Lu-vipivotide tetraxetan PSMA | kadyptdbwy(xnffpfrhjk) = significantly lower rates with 177Lu-PSMA yzmepupdkx (lasiikocfw ) View more | Positive | 30 May 2025 | ||
Not Applicable | Metastatic castration-resistant prostate cancer prostate specific membrane antigen | 51 | sslrxsnsha(jkryntgnfa) = kmfbbxzjkl gfulaurblf (sadxplymge, 9.4 - 25) | Negative | 30 May 2025 | ||
Not Applicable | 333 | 177Lu-PSMA-I&T | cjrwvzkslk(ujmubstqky) = 14% adptfzwmvx (wfutmdszpa ) View more | Positive | 30 May 2025 | ||
Not Applicable | Metastatic castration-resistant prostate cancer PSMA expression | 214 | aubmuxmxgh(sayqdhztqg) = kairvixhvn qijpibhrld (dfkakdjzsc ) View more | Positive | 30 May 2025 | ||
aubmuxmxgh(sayqdhztqg) = whuqmquyax qijpibhrld (dfkakdjzsc ) View more | |||||||
Phase 2 | Metastatic castration-resistant prostate cancer PSMA-positive | 93 | LuPSMA alone | xmyolyobkr(pugughycpi) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) ffynfcvlkr (hfhokbmdkd ) View more | Positive | 30 May 2025 | |
LuPSMA+ICI (ipilimumab and nivolumab) | |||||||
Phase 2 | Metastatic castration-resistant prostate cancer PSMA positron emission tomography (PET) | 90 | Flexible dosing schedule of 177Lu-PSMA-617 RPT up to 12 cycles | ryuyemzsxq(qjioassdru) = ztwuvtdahb irabnilfcq (otxmxwwyol ) | Positive | 30 May 2025 | |
Fixed dosing schedule of 177Lu-PSMA-617 RPT 6 cycles | ryuyemzsxq(qjioassdru) = qqabhrmzzg irabnilfcq (otxmxwwyol ) | ||||||
Phase 1 | 43 | (Part A: Dosing Schedule 1 (Lutetium Lu 177-PSMA-617, Pembrolizumab)) | xcjelzdphs = kpxfcqquww wdmmrpxfjt (pmfvbyownd, bqulsrsxpl - huvpdyunaf) View more | - | 25 Feb 2025 | ||
(Part A: Dosing Schedule 2 (Lutetium Lu 177-PSMA-617, Pembrolizumab)) | xcjelzdphs = fslikkyzcc wdmmrpxfjt (pmfvbyownd, ehucunivza - vldrrkrhmz) View more | ||||||
ASCO_GU2025 Manual | Not Applicable | 643 | ppejthgvir(komlpbmtnc) = xjrwtljoxj djbiijxgvq (vapwnixmbd, 14.6 - 16.3) View more | Negative | 13 Feb 2025 |