CIRAANO: Multimodal exploration (including radiopharmaceuticals Amyvid® and Tauvid®) of theater actors, memory athletes, and patients with various memory pathologies: evaluation of mnesic strategies and their cerebral substrates, and contribution to the treatment of memory pathologies.

Start Date04 Jun 2026

Sponsor / Collaborator

Institut National de la Santé et de la Recherche Médicale

NCT07580703

/ RecruitingPhase 1

A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects

This is a non randomized, open-label Phase I study in Chinese participants. The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called [18F]Flortaucipir Injection, which is used during a PET scan. The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).

Start Date23 Apr 2026

Sponsor / Collaborator-

NCT06723015

/ Enrolling by invitationPhase 2IIT

Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

Start Date04 Nov 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Flortaucipir F-18

100 Translational Medicine associated with Flortaucipir F-18

100 Patents (Medical) associated with Flortaucipir F-18

377

Literatures (Medical) associated with Flortaucipir F-18

01 Jun 2026·BIOMATERIALS

Carrier-free nanoassembly with dual antioxidant and anti-inflammatory activities camouflaged by melanoma cell membrane for tau-targeted therapy of Alzheimer's disease

Article

Author: Zhang, Ningnannan ; Xue, Rui ; Sun, Chunyang ; Zhang, Beibei ; Wang, Fengyu ; Wu, Jin

Targeting phosphorylated tau (p-tau) across the blood-brain barrier (BBB) represents a critical prerequisite for attenuating tau pathology and disease progression in Alzheimer's disease (AD) by alleviating oxidative stress and neuroinflammation. To address this challenge, we developed a novel carrier-free selenium-based nanoassembly stabilized by hydroxyl-rich fingolimod (FTY720), a sphingosine analogue. Following camouflaging with melanoma cell membranes and further functionalizing with T807, the resulting nanocomposite (FSMT) demonstrated robust capacity for BBB crossing and target p-tau both in vitro and in vivo. Additionally, FTY720 and nano-selenium exert remarkable antioxidant and anti-inflammatory effects by modulating the GSK-3β and NF-κB signaling pathways, respectively, thereby attenuating tau hyperphosphorylation and preventing neuronal cell death. In an okadaic acid-induced AD mouse model, the FSMT treatment not only significantly ameliorated oxidative stress and neuroinflammation, but also improved spatial learning and memory impairments. The reduction in abnormal tau aggregation following treatment was confirmed by PET-CT imaging. Overall, this p-tau-targeted biomimetic nanocomposite demonstrated excellent biocompatibility and therapeutic efficacy, presenting a translatable strategy for treating AD and other neurological disorders through analogous mechanisms.

01 Apr 2026·HUMAN BRAIN MAPPING

Cyclic 2.5D Perceptual Loss for Cross‐Modal 3D Medical Image Synthesis: T1w MRI to Tau PET

Article

Author: Kim, Symac ; Moon, Junho ; Jang, Ikbeom ; Chung, Haejun

ABSTRACT:

Positron emission tomography (PET) provides an in vivo molecular marker for various diseases, including Alzheimer's disease and related dementias (ADRD). PET has become increasingly integrated into diagnostic decision‐making, disease staging, and clinical trial enrichment. However, its widespread use remains constrained by high costs, government regulations, and the invasiveness of radiotracer injection. Modern diagnostic frameworks emphasize the importance of multimodal biomarker assessment, such as the “amyloid/tau/neurodegeneration” (A/T/N) framework for Alzheimer's disease; however, they are constrained by these barriers. Medical image synthesis or translation offers a potential solution by enabling the reconstruction of unavailable modalities. The clinical utility of PET depends on accurately capturing regional uptake patterns rather than exact voxel‐wise intensities, motivating the use of perceptual loss functions to assess higher‐level semantic features in generative models. While 2D, 3D, and 2.5D perceptual losses are utilized in 3D synthesis, each encounters challenges, including limited volumetric context, the scarcity of pretrained 3D models, and difficulty balancing optimization across anatomical planes. In this work, we address cross‐modal synthesis of tau PET from structural magnetic resonance imaging (MRI), generating 3D pseudo‐[ 18 F]flortaucipir standardized uptake value ratio (SUVR) maps from 3D T1‐weighted MR images. We propose a cyclic 2.5D perceptual loss that cyclically optimizes the axial, coronal, and sagittal planes over training phases, thereby enhancing volumetric consistency. Furthermore, we standardize PET SUVRs by scanner manufacturer, reducing inter‐manufacturer variability and better preserving high‐uptake regions. We evaluate the proposed approach on cohorts spanning the ADRD spectrum using data from the Alzheimer's Disease Neuroimaging Initiative and the Standardized Centralized Alzheimer's Disease and Related Dementias Neuroimaging cohort. Our approach is broadly applicable across various generative frameworks and achieves high quantitative and qualitative performance on diverse architectures, including U‐Net, UNETR, SwinUNETR, CycleGAN, and Pix2Pix. Notably, it achieves better agreement between synthesized SUVRs and measured PET scans in key brain regions relevant to Alzheimer‐type tau pathology. The code is publicly available at https://github.com/labhai/Cyclic‐2.5D‐Perceptual‐Loss .

10 Mar 2026·NEUROLOGY

Association of [ ¹⁸ F]Flortaucipir–PET and Plasma p-Tau217 With Tau Neuropathology in Alzheimer Disease and Other Neurodegenerative Disorders

Article

Author: Spina, Salvatore ; Boxer, Adam L. ; Miller, Bruce L. ; Soleimani-Meigooni, David N. ; Lario Lago, Argentina ; Rabinovici, Gil Dan ; Yballa, Claire ; Grinberg, Lea T. ; Rosen, Howard J. ; Seeley, William W. ; Rojas, Julio C. ; Blazhenets, Ganna ; La Joie, Renaud ; Vrillon, Agathe ; Lamore, Tia ; Jagust, William J. ; Vandevrede, Lawren ; Mejía-Pérez, Jhony

BACKGROUND AND OBJECTIVES:

Evaluating tau biomarkers in patients with autopsy data is critical for validating their sensitivity and specificity to Alzheimer disease (AD) neuropathologic changes (ADNCs). We examined associations between [¹⁸F]flortaucipir tau PET, plasma phosphorylated-tau 217 (p-tau217), and AD neuropathology in a cohort of clinically impaired participants from a tertiary dementia center.

METHODS:

This was a retrospective study conducted at the University of California San Francisco Neurodegenerative Disease Brain Bank that included all participants with a clinical diagnosis of neurodegenerative disease who underwent antemortem flortaucipir-PET and autopsy from 2013 to 2024. Flortaucipir-PET was acquired 80-100 minutes after injection and normalized to the inferior cerebellar cortex; standardized uptake value ratios (SUVRs) were extracted from the entorhinal cortex (early tau region) and the temporal meta-regions of interest (ROIs) (AD-signature region). Plasma p-tau217 was quantified using Simoa (Janssen) in 56 participants (median [interquartile range, IQR] PET-to-plasma duration: 1.6 months [0.24-3.7]). Semiquantitative rating of AD neurofibrillary tangle (NFT) burden in cortical areas was available for 56 participants. The diagnostic performance of tau PET and plasma p-tau217 was assessed using receiver operating characteristic analysis with cross-validation.

RESULTS:

We analyzed 73 participants (median [IQR] age: 67 [59-73] years, 60% male, median [IQR] PET-to-autopsy duration: 3.9 [2.1-5.1] years) with primary neuropathologic diagnosis of AD (n = 39), frontotemporal lobar degeneration (tauopathies, n = 26; nontauopathies, n = 4), chronic traumatic encephalopathy (n = 2), and Lewy body disease (n = 2). Flortaucipir SUVRs were elevated in participants with a neuropathologic diagnosis of AD compared with non-AD participants. Consistently elevated PET signal was detected in both the entorhinal cortex and temporal meta-ROIs at NFT Braak stage VI and high ADNC levels. No PET signal elevation was observed at intermediate ADNC levels. AD NFT burden correlated with local flortaucipir SUVRs and plasma p-tau217 concentrations across cortical brain regions. Plasma p-tau217 concentrations increased at Braak stages V and VI and correlated with flortaucipir SUVRs (r's ≥ 0.75). Both markers identified Braak stage V-VI levels with similarly high performance (entorhinal SUVR, area under the curve [AUC] = 0.92 [95% CI 0.91-0.93]; temporal meta-ROI SUVR, AUC = 0.91 [95% CI 0.90-0.92]; plasma p-tau217, AUC = 0.90 [95% CI 0.89-0.91]), but PET outperformed plasma p-tau217 in identifying high/intermediate ADNCs (entorhinal ROI, AUC = 0.94 [95% CI 0.94-0.95]; temporal meta-ROI AUC = 0.94 [95% CI 0.94-0.95]; plasma p-tau217, AUC = 0.89 [95% CI 0.88-0.90]).

DISCUSSION:

Flortaucipir-PET and plasma p-tau217 both displayed strong specificity for primary AD neuropathologic diagnosis but limited sensitivity for early tau co-pathology in non-AD diagnoses.

News (Medical) associated with Flortaucipir F-18

06 Mar 2025

·www.prnewswire.com

Inaugural ADDF Scientific Summit Convenes Pioneering Scientists Leading and Shaping Alzheimer's Research

Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, Receives Prestigious 2025 Melvin R. Goodes Prize, Nobel Prize of Alzheimer's Research Goodes Prize Winners Declare Future of Alzheimer's Treatment Will Rest on Combination Therapies and Precision Medicine NEW YORK and PALM BEACH, Fla., March 6, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) marked its Inaugural ADDF Scientific Summit in a momentous celebration of Alzheimer's science which brought together the most innovative and respected researchers in the field. The event, held on March 5th, featured the presentation of the esteemed Melvin R. Goodes Prize to Dr. Daniel M. Skovronsky, Chief Scientific Officer, Lilly, and President, Lilly Research Labs, and an address from Dr. Sanjay Gupta, CNN Chief Medical Correspondent, bestselling author, and practicing neurosurgeon. The Summit convened eight of the ten previous winners of the esteemed Goodes Prize for a symposium moderated by Dr. Niranjan Bose, Managing Director for Health & Life Sciences at Gates Ventures, spotlighting the cutting-edge advancements driving Alzheimer's therapeutics, biomarkers, and prevention, as well as the promising future of the field. These world-renowned scientists have each contributed novel ideas based around the biology of aging that are helping to revolutionize research. They, along with the ADDF, are leading and shaping the Alzheimer's field, propelling us toward combination therapies and precision medicine, the same strategy that has proven successful in cancer treatment. "It has been truly incredible to witness the pace of breakthroughs in Alzheimer's research over the past few years," said Dr. Howard Fillit, Co-Founder and Chief Science Officer of the ADDF. "Our trailblazing Goodes Prize recipients are catalyzing innovations that will enable us to tailor treatment approaches based on patients' individual biomarker profiles and combine drugs that target the specific causes of their disease. We are driving the next generation of care, which will use novel drugs targeting the underlying disease biology in tandem with current treatments to change the course of Alzheimer's." The Goodes Prize, recognized as the Nobel Prize of Alzheimer's research, is presented annually to a pioneering scientist to mark exceptional contributions to the Alzheimer's field. Skovronsky was recognized for his visionary work to develop critical diagnostic tests for Alzheimer's and for his leadership in developing and commercializing Kisunla, one of the first disease-modifying therapies for Alzheimer's patients. The game-changing diagnostics developed with Skovronsky's help include the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's which was developed with seed funding from the ADDF; the Tauvid PET scan, the first and only FDA-approved diagnostic for Tau in the brain; and a blood biomarker test for p-tau217 for the early diagnosis of Alzheimer's disease. "It is a profound honor to accept the 2025 Melvin R. Goodes Prize," said Skovronsky. "This recognition is a testament to the hard work and dedication of more than 35 years of Alzheimer's disease research to fight against this terrible disease. This award celebrates the power of collaboration and the unwavering commitment of the Alzheimer's Drug Discovery Foundation. Together, we can and will make history and change the world for patients everywhere." Skovronsky's work has been critical to the approvals of the first class of amyloid-targeting drugs for Alzheimer's, which offer patients options to delay disease progression for the first time and have set the foundation for the future of Alzheimer's therapies. As the next wave of therapeutics aimed at novel targets continues to advance, they can be combined with these anti-amyloids to increase efficacy and stop the disease in its tracks. "Six months ago, the ADDF celebrated the tenth anniversary of the Goodes Prize in Stockholm's City Hall, which is synonymous with the Nobel Prize. Now at our Inaugural ADDF Scientific Summit, we are once again highlighting the innovators driving progress in Alzheimer's on a global stage," said Ronald Lauder, Co-Founder and Co-Chairman of the ADDF. "Listening to our Goodes Prize scientists, it's amazing to hear how much progress has been made since my brother and I founded the ADDF in 1998 and to see the ADDF's fingerprints on the advancements we now take for granted – new drugs, new tests, and new prevention methods." Preceding the symposium, featured speaker Dr. Sanjay Gupta presented an address, highlighting the many reasons for hope as Alzheimer's science continues to make huge strides toward the next generation of treatments and prevention strategies. Gupta has earned multiple Emmy and Peabody awards for his health reporting and recently explored his own family history with Alzheimer's disease through filming a documentary, Dr. Sanjay Gupta Reports: The Last Alzheimer's Patient, which aired this past summer on CNN. "It was an honor to be a part of the ADDF's inaugural event celebrating its work for Alzheimer's patients," said Gupta. "We used to think about heart disease the way we thought about brain disease just a few years ago, as hopeless. But now that has changed. We can prevent heart disease, and thanks to exciting strides in how we treat and diagnose Alzheimer's, we will soon be able to prevent neurodegenerative diseases too. I am excited and I am optimistic about the future of Alzheimer's." About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . Media Contact: Emily Berkowitz, Senior Director of Communications, ADDF [email protected] 617-894-3540 SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

20 Feb 2025

·www.prnewswire.com

The Alzheimer's Drug Discovery Foundation Announces Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, as Recipient of Prestigious 2025 Melvin R. Goodes Prize

Skovronsky will be recognized for his extraordinary work with the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's.The Goodes Prize – referred to the Nobel Prize of Alzheimer's research – honors scientists making extraordinary and lasting contributions to the Alzheimer's field. NEW YORK, Feb. 20, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) will present its 2025 Melvin R. Goodes Prize to Daniel M. Skovronsky, MD, PhD, Chief Scientific Officer, Lilly, and President, Lilly Research Labs, at the Inaugural ADDF Scientific Summit on Wednesday, March 5th. Skovronsky will be recognized for his groundbreaking work to develop critical diagnostic tests for Alzheimer's in addition to his leadership in developing and commercializing Kisunla, one of the first disease-modifying therapies for Alzheimer's patients. Continue Reading Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, announced as the 2025 Melvin R. Goodes Prize The game-changing diagnostics developed with Skovronsky's help include the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's; the Tauvid PET scan, the first and only FDA-approved diagnostic for Tau in the brain; and a blood biomarker test for p-tau217 for the early diagnosis of Alzheimer's disease. The Goodes Prize, referred to as the Nobel Prize of Alzheimer's research, is presented annually to a leading scientist to mark exceptional contributions to the Alzheimer's field. This international award was established by the late Melvin R. Goodes to advance critical science aimed at fighting Alzheimer's disease and related dementias. "Dan is the epitome of a Goodes Prize awardee, a leading scientist who has advanced innovative and bold ideas to transform how we diagnose and develop new treatments for Alzheimer's," said Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "The Goodes Prize emphasizes our ongoing commitment to accelerating drug development for Alzheimer's and honors the legacy of Mel Goodes, a trailblazer in the pharmaceutical industry. We are thrilled to recognize Dan's outstanding work and partnership with the ADDF, which spans more than 20 years. His efforts to develop the Amyvid PET scan made recent Alzheimer's drug approvals possible, including Lilly's Kisunla, and will benefit patients now and for years to come." The Amyvid PET scan, which received early seed funding from the ADDF, is a brain imaging test that helps detect Alzheimer's disease by combining a positron emission tomography (PET) scan and an injection of Amyvid, a radioactive tracer. Amyvid was instrumental in the approval of the first disease-modifying Alzheimer's drugs – Aduhelm in 2021, Leqembi in 2023, and Kisunla in 2024 – providing the biomarker data needed for regulatory approval. "Over the past decade, we have witnessed remarkable advances in Alzheimer's research," said Dr. Daniel Skovronsky, Chief Scientific Officer, Lilly, and President, Lilly Research Labs. "It is my belief that through early detection and early intervention we can someday make Alzheimer's a preventable disease. I am deeply honored to receive the prestigious Goodes Prize award and look forward to joining fellow recipients who are leading the way in developing new treatments for Alzheimer's. The early support from the ADDF for my work, which aimed to revolutionize how we diagnose patients to ensure the right ones were included in our studies, was crucial to advancing the field, and I will always be grateful for that support." The Goodes Prize, which celebrated its 10th anniversary last year in Stockholm with a program featuring Queen Silvia of Sweden and U.S. Ambassador to Sweden Erik Ramanathan, honors scientists who are leading new approaches to developing Alzheimer's therapeutics and diagnostics. "To have pioneering scientists like Dan who have received this award out there in the field, pushing research forward, is truly a gift," said Nancy Goodes, ADDF Board Member. "The breakthroughs being made in the name of the Goodes Prize are the most meaningful legacy for my husband." The 11th annual Goodes Prize will be presented at 6:00 p.m. ET on Wednesday, March 5, 2025 during the inaugural ADDF Scientific Summit. This celebration of Alzheimer's science will be hosted by Dr. Howard Fillit and features a keynote address from Dr. Sanjay Gupta, MD, CNN Chief Medical Correspondent, bestselling author and practicing neurosurgeon. The summit will highlight nine world-renowned scientists and recipients of the Melvin R. Goodes Prize discussing therapeutics, biomarkers, prevention, and what is coming next in the field. Skovronsky will be the latest to join the ranks of these accomplished scientists who have helped bring the biology of aging to the forefront of Alzheimer's research. "The Goodes Prize represents our mission to treat, prevent, and ultimately cure Alzheimer's disease," commented Mark Roithmayr, ADDF Chief Executive Officer. "We support one of the largest and most diverse clinical development portfolios for Alzheimer's disease, and pioneering research, like Dan's, is critical to our goal of driving meaningful innovation and change in drug development." The Melvin R. Goodes Prize for Excellence in Drug Development was established in 2015 in honor of Melvin R. Goodes, former CEO of Warner-Lambert Company, who channeled his unique knowledge of the drug industry into Alzheimer's advocacy after being diagnosed with the disease. The award recognizes individual researchers whose work has significantly advanced our understanding of Alzheimer's, paving the way for potential breakthroughs in treatment and prevention. Previous Goodes Prize recipients have demonstrated tremendous innovation and perseverance in the quest for effective treatment options for Alzheimer's. Internationally lauded as the highest recognition in Alzheimer's research, the Goodes Prize has helped move the field forward by facilitating thought provoking discussions among leading scientists from academia, industry, and philanthropy in pursuit of a future free of Alzheimer's. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

28 Jun 2024

·www.fiercepharma.com

EU's drug regulator again rejects Apellis' eye med and PTC's Translarna in busy week of up-and-down decisions

Drug reviewers at the European Medicines Agency have given a thumbs up for Merck's PAH drug Winrevair and a second thumbs down to Apellis' geographic atrophy treatment Syfovre. For the second time in six months, Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy (GA) caused by age-related macular degeneration. In a release, Apellis noted that there were “multiple dissenting votes” by CHMP members to the opinion. The company added that it plans to seek a reexamination of the opinion, with a final decision expected in the fourth quarter of this year. “Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP said. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.” “In terms of safety,” the CHMP continued, “regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision.” In January of this year, the CHMP adopted its first negative opinion on Syfovre. The drug was approved by the FDA in February of 2023 and generated $275 million in sales last year despite early reports of inflammation for some users. In May, the company said that it holds an 85% share of the market in GA, but admitted to challenges with its launch. In the indication, Apellis is competing with Astellas’ Izervay, which has filed for approval in Europe. Mizuho Securities analyst Graig Suvannavejh noted that there was a 5% drop in Apellis' share price on Friday morning. "There have yet to be data convincingly demonstrating Syfovre use leading to clear, clinically meaningful functional benefit," Suvannavejh wrote in a note to clients. "Moreover, from a drug approval perspective, we view the European Medicines Agency as typically more conservative than the FDA. As such, we lower our probability of success for Syfovre's EU approval from 20% to 10%." Other CHMP rejections Syfovre was not the only drug that was beaten back by the CHMP more than once. The European drug reviewers have once again recommended not renewing the marketing authorization for PTC Therapeutics’ Translarna as a treatment for Duchenne muscular dystrophy. This negative opinion follows the European Commission’s May decision to not adopt the CHMP’s negative opinion from January. By that time, The CHMP had already reviewed and declined to renew the drug’s conditional nod twice. According to PTC, the scientific advisory group convened for the latest review concluded that the evidence of significant efficacy provided by the STRIDE trial "should not be ignored." And yet, the agency still maintained its previous stance. Now, PTC plans to request a reexamination of the CHMP’s third opinion. After that, the European Commission will make a decision. Based on the timeline of these procedures, PTC said it expects Translarna to remain on the market through the end of 2024 even if the negative opinion holds. Elsewhere, the CHMP also refused to recommend a marketing authorization for AB Science’s masitinib, a treatment for the nervous system disorder amyotrophic lateral sclerosis (ALS). The France-based company said it will ask for a reexamination. The CHMP also recommended that the marketing authorization for Advanz's Ocaliva be revoked for the treatment of patients with primary biliary cholangitis. Positive CHMP opinions Meanwhile, the CHMP this week issued positive recommendations for several therapies, including Merck’s blockbuster-to-be Winrevair for pulmonary arterial hypertension (PAH). Winrevair, which gained a high-profile approval from the FDA in March, is the first disease-modifying treatment for the condition. Winrevair, which was acquired by Merck in an $11.5 billion buyout of Acceleron in 2021, has been pegged by J.P Morgan analyst Chris Schott to achieve peak sales between $3 billion and $4 billion. The CHMP also recommended ARS Pharmaceuticals’ marketing application for the adrenaline nasal spray Eurneffy to be approved. It would become the first needle-free adrenaline option in Europe for the treatment of emergency Type 1 allergic reactions (anaphylaxis), which include those to food and insect bites. ARS expects to receive authorization from the EU in the third quarter and to launch Eurneffy in the fourth quarter. The company also hopes for approval of the product from the FDA, with a decision date set for October 2 of this year. The CHMP recommended Johnson & Johnson’s Balversa for the treatment of patients with unresectable or metastatic urothelial carcinoma, a type of bladder cancer. The FDA signed off on Balversa in the indication in January of this year, turning a 2019 accelerated approval into a full nod. Moderna’s respiratory syncytial virus (RSV) vaccine mRasvia has made the grade with the CHMP, too, gaining a recommendation for adults ages 60 and older. The shot, which was approved by the FDA four weeks ago, is the first mRNA vaccine targeting a pathogen other than the coronavirus to receive a positive opinion from the CHMP. Regeneron’s CD20xCD3 bispecific T-cell engager Ordspono (odronestamab) netted a positive opinion from the CHMP to treat two types of blood cancers—follicular lymphoma and diffuse large B-cell lymphoma. The thumbs up comes three months after the FDA sent two complete response letters to Regeneron for the same indications, questioning the timelines of the company’s confirmatory trials. The CHMP recommended Roche’s Piasky (crovalimab) for marketing authorization, just four days after the FDA endorsed it for patients age 13 and older with paroxysmal nocturnal hemoglobinuria (PNH), a rare, genetic life-threatening disorder of the immune system that causes premature breakdown of the red blood cells. The CHMP also has issued a positive opinion on Eli Lilly’s Tauvid (flortaucipir), the first drug used to image a characteristic of Alzheimer’s disease in the brain called tau pathology. The FDA signed off on Tauvid four weeks ago. Also making the grade from the CHMP was Celltrion’s Steqeyma, which is a biosimilar of J&J’s Stelara. It has been recommended for patients with Crohn’s disease, plaque psoriasis and psoriatic arthritis.

Drug ApprovalVaccineAccelerated Approval

100 Deals associated with Flortaucipir F-18

External Link

KEGG	Wiki	ATC	Drug Bank
-	Flortaucipir F-18	V04C	DB14914

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	United Kingdom	Eli Lilly Nederland BV	23 Nov 2024
Mild cognitive disorder	United Kingdom	Eli Lilly Nederland BV	23 Nov 2024
Contrast agents	European Union	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	Iceland	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	Liechtenstein	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	Norway	Eli Lilly Nederland BV	22 Aug 2024
Alzheimer Disease	United States	Avid Radiopharmaceuticals, Inc.	28 May 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neurodegenerative Diseases	Phase 3	United States	Avid Radiopharmaceuticals, Inc.	23 Aug 2016
Brain Injuries, Traumatic	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Dec 2014
Depressive Disorder	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Dec 2014
Cognitive Dysfunction	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Corticobasal degeneration	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Dyskinesias	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Lewy Body Disease	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Pick Disease of the Brain	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Supranuclear Palsy, Progressive	Phase 2	Sweden	Avid Radiopharmaceuticals, Inc.	19 Sep 2014
Chronic Traumatic Encephalopathy	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Jun 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02736695 (SLD3, CTgov)	Phase 1	Frontotemporal Dementia \| Aphasia, Primary Progressive	81	F-18 AV 1451	leplgvwtpr = hrpsxsuozz liaiiexrzb (ahjghiknik, oresyhhkzb - geyzfdbwqr) View more	-	21 Nov 2025
NCT02350634 (CTgov)	Phase 1	Alzheimer Disease	3	Flortaucipir F18	mhhczaaxvv = bqtbibmpjn eoulohszst (uadpfmvbnj, urqedkphnm - rjppjqahjh) View more	-	10 Jun 2025
NCT04080544 (CTgov)	Phase 2	Alzheimer Disease \| Cognitive Dysfunction	125	Positron Emission Tomography+[18F]AV-1451	mowumrpnzy(kdhiozeohl) = agokbqapkw mbpsvzxgxd (zllwunwqmk, 0.10) View more	-	28 Sep 2023
NCT03040713 (CTgov)	Phase 1	Frontotemporal Dementia With Motor Neuron Disease \| Frontotemporal Dementia	16	Brain PET scan+Flortaucipir F18	xqnfrtiynv(xhnqvyctvc) = tbdkyjjqee pobpnesibo (qplgitsxna, 0.036582) View more	-	25 Sep 2020
NCT04474405 (CTgov)	Early Phase 1	Alzheimer Disease \| Cognitive Dysfunction \| Mild cognitive disorder	36	Whole body PET scan+Flortaucipir F18 (Whole Body Flortaucipir PET Scan)	qmdrbkxsku(uqbiycrqrt) = uhxczroziu svwpbevmnn (rvnmusozol, 0.00160) View more	-	25 Sep 2020
				Brain MRI+Florbetapir F 18 (MRI and Amyloid Extension Cohort)	ggiejqbfwo(sqlbohbtjc) = ynsxcmzmra nhhzpyioxf (rwlpphtzkp, awlzbzlywt - lwalyapkwy) View more
NCT02278367 (CTgov)	Phase 2	Alzheimer Disease \| Depressive Disorder \| Brain Injuries, Traumatic	179	flortaucipir (Cognitively Impaired)	utuxoahkqh = bzfeyeekyq seqpnsdism (gnnyeylewx, imonaqdcig - wpvzpoqbux) View more	-	10 Sep 2020
				flortaucipir (Cognitively Normal)	utuxoahkqh = hrfofjroki seqpnsdism (gnnyeylewx, wnzqodwwbr - tvddphfvhj) View more
NCT01992380 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction \| Mild cognitive disorder	24	Brain PET scan+Flortaucipir F18 (Healthy Volunteer Subjects)	shwmaqrria(dnemketcjz) = ojusfquffp vbsjkozvdk (slegqwwkgi, mqzqdbubrb - nsnleixfaa) View more	-	07 Sep 2020
				Brain PET scan+Flortaucipir F18 (MCI Subjects)	shwmaqrria(dnemketcjz) = ptmbpfbjjp vbsjkozvdk (slegqwwkgi, hooinknixv - shcmwjvjws) View more
NCT02051764 (CTgov)	Phase 2	Alzheimer Disease	44	flortaucipir (Cognitively Impaired)	iiqhlxiifj(yovkqrjtfl) = zjvwugpkhj yniugahkbf (odluyaexgy, 0.047) View more	-	07 Sep 2020
				flortaucipir (Healthy Volunteers)	iiqhlxiifj(yovkqrjtfl) = xkvdgbbvkm yniugahkbf (odluyaexgy, 0.013) View more
NCT03322462 (CTgov)	Phase 2	Alzheimer Disease	155	flortaucipir (Early Symptomatic AD, Eligible for AACG Study)	tjdbbtkxfq(husxilsmwt) = gnfmvcwkop lkijcvfsiv (xfpearhlcz, 0.119729) View more	-	24 Aug 2020
				flortaucipir (Early Symptomatic AD, Ineligible for AACG Study)	tjdbbtkxfq(husxilsmwt) = tberuycmng lkijcvfsiv (xfpearhlcz, 0.316435) View more
NCT02795780 (CTgov)	Phase 2	Alzheimer Disease	79	flortaucipir (AD Aβ+ Subjects)	qcklgolzab(fnitwshdqe) = iahxbwaftn pduvznlavi (nayhkkilpm, 0.01871)	-	24 Aug 2020
				flortaucipir (AD Aβ- Subjects)	qcklgolzab(fnitwshdqe) = ipvomgotxb pduvznlavi (nayhkkilpm, 0.03619)

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