Because innovation fuels our 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.

Legend:
  • Diagnostic
  • Therapeutic
Preclinical Phase 1 Phase 2 Phase 3 Reg. Filing Market

Microbubble

       
Phase 3
     

TARGET:N/A

ISOTOPE:N/A

DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information and full Prescribing Information at www.definityimaging.com).1

Radiopharmaceuticals

Prostate Cancer 		      
Ref. Filing
     

TARGET:PSMA

ISOTOPE:18F

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated in the U.S. for positron emission tomography of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and also for men with suspected recurrence based on elevated serum prostate-specific antigen level. (See Indications and Important Safety Information and full Prescribing Information at www.PYLARIFY.com). Curium has exclusive rights to develop, manufacture and commercialize PYLARIFY in Europe and has filed a registration dossier to the European Medicines Agency.

Out-Licensed to Curium for Europe.
PSMA = Prostate specific membrane antigen
Phase 3
     

TARGET:PSMA

ISOTOPE:177Lu

PNT2002 is a small molecule PSMA-targeted 177Lu-based radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. PNT2002 is currently in its Phase 3 clinical study designed to evaluate superiority to the standard of care in mCRPC pre-chemotherapy patients who have failed one androgen receptor pathway inhibitor (SPLASH study – NCT04647526).

PSMA = Prostate specific membrane antigen
Phase 2
     

TARGET:PSMA

ISOTOPE:131I

LNTH-1095 (also known as MIP-1095) is a small molecule PSMA-targeted 131I-based radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, LNTH-1095, with the beta-emitting radioisotope 131I. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre-chemotherapy patients in the U.S. and Canada (ARROW study – NCT03939689).

PSMA = Prostate specific membrane antigen
Phase 3
     

TARGET:PSMA

ISOTOPE:99mTc

1404 is a Tc-99m-labeled molecule which binds to PSMA and is used as a SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP has exclusive rights to develop, manufacture and commercialize 1404 in Europe.

Out-Licensed to Rotop Pharmaka GmbH.
PSMA = Prostate specific membrane antigen
Phase 1
     

TARGET:PSMA

ISOTOPE:225Ac

PSMA-TAC (225Ac-pelgifatamab) is a PSMA-targeted antibody in initial stage of development for the treatment of metastatic castration-resistant prostate cancer. PSMA-TAC is out-licensed to Bayer Pharmaceuticals.

Out-Licensed to Bayer Pharmaceuticals.
PSMA = Prostate specific membrane antigen
Preclinical
     

TARGET:PSMA

ISOTOPE:TBD

LNTH-1558 is a small molecule PSMA-targeted agent in pre-clinical development phase. Current work is aimed at obtaining a drug candidate with an optimal biodistribution profile.

PSMA = Prostate specific membrane antigen
Neuro-Endocrine Tumors       
Phase 3
     

TARGET:SSTR2

ISOTOPE:177Lu

PNT2003 is a somatostatin receptor (SSTR) targeted radioligand therapy with no-carrier-added 177Lu, in development for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). PNT2003 is currently being evaluated in a Phase 3 clinical trial.

SSTR2 = Somatostatin receptor 2
Tumor Micro-Environment       
Phase 2
     

TARGET:PD-L1

ISOTOPE:99mTc

NM-01 is a SPECT imaging agent that targets the PD-L1 receptor and can provide whole-body imaging assessment in a single examination. It is currently being developed for the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) patients and for its potential to identify patients who will respond to checkpoint inhibitor therapies.

PD-L1 = Programmed death-ligand 1
Preclinical
     

TARGET:FAP

ISOTOPE:64Cu

NTI-1309 is an imaging biomarker that targets fibroblast activation protein (FAP), an emerging target with broad potential imaging applicability and use in oncology. Upon further clinical development, we will assess options to bring NTI-1309 to market as a diagnostic or potentially a therapeutic agent.

FAP = Fibroblast activation protein
Cardiology       
Phase 3
     

TARGET:MC-1

ISOTOPE:18F

Flurpiridaz is a 18F PET agent designed to assess myocardial perfusion. We have out-licensed Flurpiridaz to GE Healthcare, who is responsible for the completion and commercialization of the imaging agent.

Out-Licensed to GE Healthcare.
MC-1 = Mitochondrial complex 1
Neurology       
Phase 1
     

TARGET:Tau

ISOTOPE:18F

MK-6240 is a clinical stage 18F PET development candidate designed to detect Tau protein in the form of neurofibrillary tangles in the brains of patients with known or suspected Alzheimer’s disease. MK-6240, currently used as biomarker in Alzheimer’s disease clinical trials, has the potential to aid in diagnosing, staging, and informing treatment selection and response to therapy for Alzheimer’s disease.

Each of these product candidates is an investigational drug that has not yet been approved as safe and effective.

*We are actively partnering with researchers on these assets to provide appropriate biomarkers in relevant studies.  If interested, please contact pharmasolutions@lantheus.com for more information.

References:
  1. DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.

Clinical Trials

Lantheus is committed to Find, Fight and Follow® disease for patients. As part of that commitment, we ensure that Diversity, Equity and Inclusion (DEI) is a top priority when it comes to clinical trials. Because we believe everyone should have access to the latest trials and treatments.

For more information about clinical trials involving products being developed by Lantheus, please contact our clinical team at 978-671-8350.

Information on all clinical trials involving products being developed by Lantheus is offered by the National Institutes of Health here:

Digital and Pharmaceutical Services

Our innovation includes the very latest technologies in digital and pharmaceutical services. We’re pioneering AI software platforms that use deep learning algorithms to help clinicians and researchers perform quantitative assessments in cancer imaging. This focus on data-driven solutions helps us partner with healthcare professionals to empower more informed diagnostic and treatment decisions that can lead to improved patient outcomes.

Partnering with Lantheus

Expanded Access Program

LANTHEUS is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. We are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products and to obtain regulatory approval, thereby making our medicines available to patients who are most likely to benefit from this therapy, as quickly as possible.

At the same time, we understand that there are individuals who may have exhausted all available treatment options and may not be eligible for available clinical trials. For this reason, although expanded access is not yet an option for any of LANTHEUS’ investigational radioligands, we are working diligently with our partner POINT to establish a 177Lu-PNT2002 Expanded Access Program in the United States. More information will be available once agreement on the protocol has been reached with FDA.