Pipeline
As we think about the future of medicine, we’re exploring new frontiers across a diverse and robust range of product candidates and disease states. All with the vision of developing game-changing solutions for patients.
Prostate cancer
| Candidate | Target | Isotope | Indication/Disease Area | Pre-Clin. | Phase 1 | Phase 2 | Phase 3 | Reg. Filing |
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| Piflufolastat F 181,2 | Target: PSMA | Isotope: 18F |
Indication/Disease Area: Prostate cancer |
Phase: Reg. Filing
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A new formulation of piflufolastat F 18 injection with an increased radioactive concentration is being developed for patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy and for those with suspected recurrence based on an elevated serum prostate-specific antigen level. |
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| LNTH-24013 | Target: GRPR | Isotope: 68Ga |
Indication/Disease Area: Metastatic prostate cancer |
Phase: Phase 2
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LNTH-2401 is a novel radiodiagnostic targeting the gastrin-releasing peptide receptor. |
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| LNTH-24024 | Target: GRPR | Isotope: 177Lu |
Indication/Disease Area: Metastatic prostate cancer |
Phase: Preclinical
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LNTH-2402 is a novel gastrin-releasing peptide receptor targeted radiotherapeutic for solid tumors including prostate, breast, lung and other cancers. |
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Neuroendocrine tumors
| Candidate | Target | Isotope | Indication/Disease Area | Pre-Clin. | Phase 1 | Phase 2 | Phase 3 | Reg. Filing |
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| PNT20035 | Target: SSTR+ | Isotope: 177Lu |
Indication/Disease Area: GEP-NETs |
Phase: Reg. Filing
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PNT2003 is a somatostatin receptor targeted radiotherapeutic, in development for gastroenteropancreatic neuroendocrine tumors. |
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| LNTH-2501/EVG-001 | Target: SSTR+ | Isotope: 68Ga |
Indication/Disease Area: Neuroendocrine tumors |
Phase: Reg. Filing
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LNTH-2501/EVG-001 is a diagnostic kit for the preparation of Ga-68 edotreotide Injection, indicated for use with PET imaging for the localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients. |
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Other solid tumors
| Candidate | Target | Isotope | Indication/Disease Area | Pre-Clin. | Phase 1 | Phase 2 | Phase 3 | Reg. Filing |
|---|---|---|---|---|---|---|---|---|
| LNTH-1363S* | Target: FAP | Isotope: 64Cu |
Indication/Disease Area: Tumor/fibrosis assessment |
Phase: Phase 1
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LNTH-1363S is a fibroblast activation protein, copper-64 labeled radiodiagnostic with broad potential imaging applicability and use in oncology. |
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| LNTH-2403 | Target: LRRC15 | Isotope: Undisc. |
Indication/Disease Area: Solid tumors |
Phase: Preclinical
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LNTH-2403 is a leucine-rich repeat-containing protein 15 targeted radiotherapeutic. It received Orphan Drug and Rare Pediatric Disease designations from the U.S. FDA for the treatment of osteosarcoma. |
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| LNTH-2404 | Target: TROP2 | Isotope: Undisc. |
Indication/Disease Area: Solid tumors |
Phase: Preclinical
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LNTH-2404 is a trophoblast cell surface antigen-2 targeted radiotherapeutic. |
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| LNTH-2503/EVG-321 | Target: CCK2R | Isotope: 177Lu/68Ga |
Indication/Disease Area: Small cell lung cancer |
Phase: Phase 1
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LNTH-2503/EVG-321 is a highly specific peptide vector, which binds to the cholecystokinin-2 receptor (CCK2), a highly expressed tumor marker in cancers like small cell lung cancer (SCLC). |
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| LNTH-2505/EVG-311 | Target: Undisc. | Isotope: 177Lu/68Ga |
Indication/Disease Area: Glioblastoma |
Phase: Preclinical
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LNTH-2505/EVG-311 is a molecularly targeted tracer that binds to a glial cell surface molecule which may be used for the diagnosis and treatment of glioblastoma (GBM) and potentially other glial tumors. |
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| LNTH-2507/EVG-332 | Target: Undisc. | Isotope: 177Lu/68Ga |
Indication/Disease Area: PDAC |
Phase: Preclinical
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LNTH-2507/EVG-332 is a radiotracer targeting a cell surface molecule for the treatment of pancreatic ductal adenocarcinoma (PDAC). |
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| LNTH-2509/EVG-341 | Target: Undisc. | Isotope: 177Lu/68Ga |
Indication/Disease Area: Lobular breast cancer |
Phase: Preclinical
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LNTH-2509/EVG-341 is a radiotracer targeting a cell surface molecule for the treatment of lobular breast cancer. |
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Neurology/other
| Candidate | Target | Isotope | Indication/Disease Area | Pre-Clin. | Phase 1 | Phase 2 | Phase 3 | Reg. Filing |
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| MK-6240* (florquinitau) | Target: Tau | Isotope: 18F |
Indication/Disease Area: Alzheimer’s disease |
Phase: Reg. Filing
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Florquinitau is a next-generation tau-targeting radiodiagnostic for Alzheimer’s disease. |
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| NAV-4694* (flutafuranol) | Target: ß amyloid | Isotope: 18F |
Indication/Disease Area: Alzheimer’s disease |
Phase: Phase 3
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| LNTH-2620/PI-2620 | Target: Tau | Isotope: 18F |
Indication/Disease Area: Tau imaging |
Phase: Phase 3
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LNTH-2620/PI-2620 is an F-18 labeled small molecule specifically targeting tau used as a radiodiagnostic in conjunction with PET imaging to show aggregated tau protein in people with Alzheimer’s disease and other tauopathies. It binds to both isoforms of tau (4R and 3R/4R repeats). The FDA has granted Fast Track designation for the development of LNTH-2620/PI-2620 in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). |
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| LNTH-2511/DED | Target: MAO-B | Isotope: 18F |
Indication/Disease Area: Neuroinflammation |
Phase: Phase 1
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LNTH-2511/DED is an F-18 labeled small molecule specifically targeting reactive astrocytes during neuroinflammation, which presents in diseases such as Alzheimer’s disease, multiple sclerosis, amyotrophic lateral sclerosis (ALS) and Parkinson’s disease. |
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| LNTH-2513/GP1 | Target: GPIIb-IIIa | Isotope: 18F |
Indication/Disease Area: Thromboembolism |
Phase: Phase 2
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LNTH-2513/GP1 is a small F-18 labeled molecule, specifically designed to image active thrombi (new blood clots) by binding to activated GPllb/llla receptors, which are involved in thrombus formation and propagation. LNTH-2513/GP1 is the first PET tracer shown to be able to detect acute thromboembolic events in humans. |
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| LNTH-2515/Florbetaben | Target: Amyloid | Isotope: 18F |
Indication/Disease Area: Cardiac amyloid imaging |
Phase: Phase 3
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LNTH-2515/Florbetaben is an F-18 labeled radiodiagnostic stilbene derivative that binds to amyloid deposits and is being studied in patients with cardiac amyloidosis. The FDA has granted Fast Track designation for the development of LNTH-2515/Florbetaben imaging for the diagnosis of AL (amyloid light chain) and ATTR (transthyretin amyloid cardiomyopathy) cardiac amyloidosis. |
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Each of these product candidates is an investigational drug that has not yet been approved as safe and effective.
PSMA, prostate-specific membrane antigen; GRPR, Gastrin-releasing peptide receptor; SSTR+, Somatostatin receptor-positive; GEP-NETs, Gastroenteropancreatic neuroendocrine tumors; FAP, Fibroblast activation protein; LRRC15, Leucine-rich repeat-containing protein 15; TROP2, Trophoblast cell surface antigen-2; CCK2R, Cholecystokinin-2 receptor; PDAC, Pancreatic ductal adenocarcinoma; MAO-B, Monoamine oxidase-B; GPIIb-IIIa, Glycoprotein IIb-IIIa.
1. Piflufolastat F 18 was approved by the U.S. FDA in May 2021 for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level. The new formulation is being developed for this same population. 2. Pending FDA approval. 3. Also known as 68Ga-RM2. 4. Also known as 177Lu-RM2. 5. Collaboration with POINT Biopharma Global Inc.
*We are actively partnering with researchers on these assets to provide appropriate biomarkers in relevant studies. If interested, please contact biomarkers@lantheus.com for more information.
