Last update 28 May 2025

Gallium GA-68 Gozetotide

Overview

Basic Info

Drug Type
Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals
Synonyms
(68)Ga Labeled Glu-NH-CO-NH-Lys(ahx)-hbed-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
+ [30]
Target
Action
inhibitors
Mechanism
PSMA inhibitors(Prostate-specific membrane antigen inhibitors)
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Structure/Sequence

Molecular FormulaC44H55GaN6O17
InChIKeyAEBYHKKMCWUMKX-LNTZDJBBSA-G
CAS Registry1906894-20-9
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
PSMA-Positive Prostatic Cancer
Germany
15 Jan 2025
PSMA-Positive Castration-Resistant Prostatic Cancer
European Union
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
Iceland
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
Liechtenstein
09 Dec 2022
PSMA-Positive Castration-Resistant Prostatic Cancer
Norway
09 Dec 2022
Metastatic Prostate Carcinoma
Australia
10 Nov 2021
Prostatic Cancer
United States
01 Dec 2020
Prostatic Cancer
United States
01 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-metastatic prostate cancerPhase 3
China
19 Jul 2023
Non-metastatic prostate cancerPhase 3
China
19 Jul 2023
Metastatic castration-resistant prostate cancerPhase 3
United States
09 May 2022
Salivary Gland Adenoma, PleomorphicPhase 3
United States
20 May 2017
Recurrent Prostate CarcinomaPhase 3
United States
15 Sep 2016
Adenocarcinoma of prostatePhase 3
United States
18 Apr 2016
Adenoid Cystic CarcinomaPhase 2
United States
12 Aug 2024
GliomaPhase 2
United States
26 Jul 2024
Malignant glioma of brainPhase 2
United States
26 Jul 2024
Recurrent GliomaPhase 2
United States
26 Jul 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
6
rsibrmbtjt = vrztgjvwru pbicqjahre (nblxsabvlm, btdosentaw - mrtlodtgol)
-
17 Apr 2025
Not Applicable
462
(PSA <0.5 ng/mL + Imaging Prior to Suspected Recurrence Therapy)
urwlqmwszd(vdvjfzloqq) = ncxfhfijrz cxxvvqroxe (dkztlybbje, 27 - 44)
Positive
20 Mar 2025
(PSA ≥0.5 and <1 ng/mL + Imaging Prior to Suspected Recurrence Therapy)
urwlqmwszd(vdvjfzloqq) = zxthcisiss cxxvvqroxe (dkztlybbje, 45 - 67)
Not Applicable
123
(Imaging Prior to Initial Definitive Therapy)
qgfuijbjjk(zujrcmztnh) = kuyebxdrlx vkbrdwxlmj (eyjndpsrsl, 29 - 65)
Positive
20 Mar 2025
Phase 2
7
fdrynwjeqe = swddvmtjpq aogpjfxxtf (mlvgadiexi, ekigsuwdbo - uymdgcfznn)
-
28 Feb 2025
Phase 2
15
Positron Emission Tomography (PET)+68Ga-PSMA-11
txmjtxwuow = ipaufuxnbx xwamfxybja (swpisqbofh, cwtgonhrok - fuwnpdpjbw)
-
16 Oct 2024
Not Applicable
-
-
Ga-68 PSMA-11MA-11 Radiotracer
(Ga-68 PSMA-11 radiotracer)
lkuheyrqwb(kgxonnfprw) = tmfhxfooyi kpbemahpxu (dgwwwsduwk )
-
01 Oct 2024
Not Applicable
-
68Ga Prostate-Specific Membrane Antigen
(68Ga-prostate specific membrane antigen (PSMA))
fmdgxyhaug(tazyrhnxfs) = yvgafdmkmk myxgouqqmu (klidnotqrf )
-
01 Oct 2024
fmdgxyhaug(tazyrhnxfs) = bcqmxpxxcy myxgouqqmu (klidnotqrf )
Not Applicable
Prostatic Cancer
PSA | Gleason Score | MSKCC nomogram
103
(Patients with Ga-68 PSMA PET/CT)
ngpgvqzaey(vluqibyywh) = uykgnqwbnc xxowftzyqq (wkmitqpoza )
-
27 Sep 2024
Not Applicable
68Ga-PSMA-11 PET uptake metrics
-
jvltpmowgf(zimpavmgby) = gicbpzenwf ivacmlkddl (injstawfyg, 1.7)
-
27 Sep 2024
Not Applicable
PSMA receptor
3
rjybqyyvcq(lvftsyowxu) = zsgoczkpfi aeipjyzntv (qegldtdgfn )
-
27 Sep 2024
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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