Preclinical Phase 1 Phase 2 Phase 3 Reg. Filing Market
Prostate Cancer       
Phase 2

1095 (also known as I-131-1095) is a PSMA-targeted iodine-131-labeled radiopharmaceutical that is designed to deliver a dose of beta radiation directly to prostate cancer cells, with minimal impact on the surrounding healthy tissues. We are conducting a phase 2 trial of 1095 in subjects with metastatic castration-resistant prostate cancer (mCRPC) in the U.S. and Canada.

Prostate cancer is the second leading cause of all male cancer deaths in the U.S.1

Phase 3

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.

In 2020, more than 1.4M men worldwide were diagnosed with prostate cancer.2

Brain Cancer       
Phase 2

Carthera will use our microbubbles in combination with SonoCloud®, a proprietary implantable device in development for the treatment of recurrent glioblastoma.

Glioblastoma is a lethal and devastating form of brain cancer with median survival of 15 months after diagnosis.3

Phase 1

Insightec will use our microbubbles in connection with its MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions.

Glioblastoma is the most aggressive malignant primary brain tumor, affecting 3.19 American patients per one hundred thousand, and has a less than 5% five-year survival rate.4

Cancer Biomarkers       
Phase 2

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.

Lung cancer is the second most diagnosed cancer in the world. And NSCLC accounts for 82% of all lung cancer diagnoses in the United States, making it the most common type of lung cancer in Americans.5


NTI-1309 is an imaging biomarker that targets fibroblast activation protein (FAP), an emerging target with broad potential imaging applicability and use in oncology. We licensed NTI-1309 from Ratio Therapeutics, Inc. in March of 2021. Ratio will drive the early clinical development of NTI-1309 and upon completion of the phase 1 study, NTI-1309 will be integrated into our pipeline.

Phase 3

Flurpiridaz F 18 is a fluorine 18-based PET MPI agent designed to assess blood flow to the heart. On April 25, 2017, we announced entering into a definitive, exclusive Collaboration and License Agreement with GE Healthcare for the agent’s continued phase 3 development and worldwide commercialization.

Phase 1

Cerevast treatment for retinal vein occlusion will use our microbubble in combination with its ocular ultrasound device to target improving blood flow in occluded retinal veins in the eye. This therapy has the potential to reduce or eliminate the need for chronic maintenance therapy and improve the quality of life for those patients inflicted by retinal vein occlusion.

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

  1. Key Statistics for Prostate Cancer. American Cancer Society. Published January 12, 2022. Accessed May 18, 2022.,Survival%20Rates%20for%20Prostate%20Cancer
  2. Prostate Cancer: Statistics. Cancer.Net. Published April 14, 2022. Accessed June 10, 2022.
  3. Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207-12.
  4. Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, ed. Glioblastoma. Brisbane (AU): Codon Publications; September 27, 2017.
  5. Lung Cancer—Non-Small Cell: Statistics. Cancer.Net. Published April 14, 2022. Accessed August 23, 2022.

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.