Life Molecular Imaging Receives Orphan Drug Designations for its Tau Tracer PI-2620 as Diagnostic Tool for Progressive Supranuclear Palsy and Corticobasal Degeneration

Orphan Drug Designations in EU and U.S. accompanied by seminal clinical publications

BERLIN, Germany, 20 May 2021 – Life Molecular Imaging (LMI) announces today that PI-2620 has been granted four different orphan drug designations, two by the European Commission and two by the U.S. Food and Drug Administration. The designations in Europe cover diagnosis of Progressive Supranuclear Palsy (PSP) and diagnosis of Corticobasal Degeneration (CBD). The U.S. designations have been granted for the clinical management of PSP and clinical management of CBD. With this, PI-2620 is the first and only imaging agent for positron emission tomography (PET) to receive orphan drug designation for the diagnosis of PSP and CBD.

PSP and CBD are both rare and rapidly progressive neurodegenerative diseases that can lead to premature death. It can be challenging to diagnose patients based on symptoms, such as movement difficulties, stiffness, clumsiness, cognitive impairment and frequent falls, because they are also present in other, non-tau-related neurodegenerative diseases, like Parkinson’s disease (PD). Misdiagnosis of PSP and CBD, especially in the early stages of the diseases, hampers drug development due to heterogeneous study populations that inadvertently mix patients with tau-related pathologies with patients suffering from other proteinopathies.

The orphan drug designations are accompanied by recent clinical data, which established the ability of PI-2620 to reliably detect the characteristic 4-repeat (4R)-tau depositions in PSP and CBD cohorts through PET imaging [1,2]. These seminal clinical results further demonstrate PI-2620’s excellent characteristics as a unique diagnostic tool for studying 4R-tau-related diseases, in addition to its strong performance in AD [3]. PI-2620 can aid in the diagnosis of PSP and CBD patients earlier and more reliably, allowing differentiation of these tauopathies from other neurodegenerative diseases [1,2].

“The orphan medicinal product designations for PI-2620 strengthen our development program for the indications of PSP and CBD. This innovative and differentiated diagnostic tool is available to physicians and patients worldwide and can already be used as investigational medicinal product in research studies with tauopathy patients. The latest clinical results encourage further research and development of this imaging technology towards a fully validated tracer. Once approved, PI-2620 may facilitate earlier and more accurate diagnosis of not only Alzheimer’s Disease, but also PSP and CBD, enabling better management of these diseases,” said Andrew Stephens, MD, PhD, Chief Medical Officer of LMI.

Prof. Dr. Günter Höglinger, Director of the Department of Neurology at Hannover Medical School, added: “It is a big step forward to finally have an objective diagnostic procedure within reach for assessment of tau pathology in various cortical and subcortical sites. The next important steps are to investigate the usefulness of PI-2620 as a progression biomarker and as a possible target-engagement marker for therapeutic studies.”


  1. Brendel M et al. “Assessment of 18F-PI-2620 as a Biomarker in Progressive Supranuclear Palsy” JAMANeurology 77(11):1408-1419
  2. Palleis C, et al. “Cortical [18 F]PI-2620 Binding Differentiates Corticobasal Syndrome Subtypes” Mov Disord. 2021 May 5.
  3. Mueller A et al. “Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study” J Nucl Med. 2020 Jun;61(6):911-919.

About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit

About Life Healthcare Group
Life Healthcare Group is a market-leading, international, diversified healthcare organization. Life Healthcare has over 33 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and employee health and wellness services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services within Europe, operating across 10 international countries. Visit

About PI-2620
PI-2620 was discovered in a research collaboration with Life Molecular Imaging and AC Immune. Life Molecular Imaging has the exclusive world-wide license for research, development and commercialization of tau-PET tracers generated within the discovery program. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of tau deposits in the human brain.

Media Contact:

Nicole Fletcher
Marketing Communications | Life Molecular Imaging
Tel. +1 857-202-1122

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.



  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.


  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).


  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.


  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
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  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.