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Last update 28 May 2025
Radiprodil
Last update 28 May 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms NP 121, RGH-896, UCB-3491 |
Target |
Action antagonists |
Mechanism GluN2B antagonists(Glutamate [NMDA] receptor subunit epsilon 2 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhasePhase 1/2 |
First Approval Date- |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), PRIME (European Union) |
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Structure/Sequence
Molecular FormulaC21H20FN3O4 |
InChIKeyGKGRZLGAQZPEHO-UHFFFAOYSA-N |
CAS Registry496054-87-6 |
Related
12
Clinical Trials associated with RadiprodilNCT06975605
Phase 1, Open-label, 3-period Study to Evaluate Drug-Drug Interaction Potential of Radiprodil With Cocktail Probes Representative of CYP3A4, CYP2C9, CYP2C19, P-gp and BCRP in Healthy Adult Subjects
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted in 1 cohort of healthy adult participants only.
Start Date20 May 2025 |
Sponsor / Collaborator |
NCT06965881
A Phase 1, Open-label, 2-part Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of a CYP3A4 Inducer (Carbamazepine) or Inhibitor (Itraconazole), With Radiprodil in Healthy Adult Participants
This is a Phase 1, open-label, 2-part study to evaluate the effect of multiple doses of oral carbamazepine or oral itraconazole on the plasma pharmacokinetic profile of radiprodil in healthy adult participants. In addition, the safety and tolerability of radiprodil given together with oral carbamazepine or itraconazole will be assessed.
Start Date08 May 2025 |
Sponsor / Collaborator |
ACTRN12624001440516
An Open-label, 2 Part, Study to Assess the Pharmacokinetics of a Spray Dried Dispersion Formulation of Radiprodil Under Fasted and Fed Conditions in Healthy Adult Subjects: Part B
Start Date16 Jan 2025 |
Sponsor / Collaborator |
100 Clinical Results associated with Radiprodil
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100 Translational Medicine associated with Radiprodil
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100 Patents (Medical) associated with Radiprodil
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26
Literatures (Medical) associated with Radiprodil01 Mar 2025·BIOORGANIC & MEDICINAL CHEMISTRY
Design, synthesis, and evaluation of the pharmacological activity of novel NMDA receptor antagonists based on the germacrone scaffold
Article
Author: Wang, Shi ; Cheng, Maosheng ; Ma, Chao ; Shi, Chaohui ; Fang, Fang ; Xu, Yang ; Zhang, Yue ; Zhang, Yuanhu ; Song, Pengfei ; Mao, Qingqiu ; Huang, Xian ; Xu, Lang
The NMDA receptor has long attracted researchers' attention due to its potential as a drug target and its central role in the central nervous system. The NMDA receptor is a ligand-gated and voltage-dependent ion channel widely distributed in the central nervous system. In this study, we employed a drug design strategy combining "molecular assembly" and "combinatorial chemistry." By reducing the carbonyl group of germacrone to a hydroxyl group and esterifying it with alanine and linarinic acid, we successfully obtained nine novel germacrone derivatives through two rounds of structural optimization. We evaluated the neuroprotective activity of these nine derivatives using the MTT assay. The results revealed that compound C1 exhibited particularly outstanding activity, achieving a cell protection rate of 29.63 ± 1.56 % at a concentration of 0.05 μM, outperforming the positive control drug, ifenprodil. Further experiments on NMDA-induced Ca2+ influx verified that the action site of compound C1 was the NMDA receptor, and demonstrated its superior antagonistic effect on the NMDA receptor compared to germacrone and ifenprodil. Additionally, molecular docking studies and ADMET property predictions were conducted for compound C1. The results showed that compound C1 tightly bound to the active site of the NMDA receptor and possessed favorable pharmacokinetic properties. In conclusion, compound C1, characterized by a germacrone-linarinic acid structure, not only exhibits strong antagonistic effects on the NMDA receptor but also demonstrates excellent pharmacokinetic properties, indicating its potential for further development as a therapeutic drug for central nervous system diseases.
01 Oct 2024·EPILEPSIA
Progress report on new medications for seizures and epilepsy: A summary of the 17th Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVII). II. Drugs in more advanced clinical development
Article
Author: White, H. Steve ; Johannessen, Svein I. ; Perucca, Emilio ; Tomson, Torbjörn ; Koepp, Matthias J. ; Bialer, Meir ; Perucca, Piero
Abstract:
The 17th Eilat Conference on New Antiepileptic Drugs and Devices took place in Madrid, Spain on May 5–8, 2024. As usual, the core part of the conference consisted of presentations on investigational drugs at various stages of development for epilepsy‐related indications. Summaries of information on compounds in preclinical or early clinical development are included in an accompanying publication (Part I). In this article, we provide summaries for five compounds in more advanced clinical development, i.e. compounds for which some information on antiseizure activity in individuals with epilepsy is available. These investigational treatments include azetukalner (XEN1101), a potent, KV7.2/7.3‐specific potassium channel opener in development for the treatment of focal seizures, generalized tonic–clonic seizures, and major depressive disorder; bexicaserin (LP352), a selective 5‐HT2C receptor superagonist in development for the treatment of seizures associated with developmental and epileptic encephalopathies; radiprodil, a selective negative allosteric modulator of NR2B subunit‐containing N‐methyl‐D‐aspartate glutamate receptors, in development for the treatment of seizures and behavior manifestations associated with disorders caused by gain‐of‐function mutations in the GRIN1, −2A, ‐2B, or ‐2D genes; soticlestat (TAK‐935), a selective inhibitor of cholesterol 24‐hydroxylase in development for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome; and STK‐001, an antisense oligonucleotide designed to upregulate Nav1.1 protein expression and improve outcomes in individuals with Dravet syndrome. The diversity in mechanisms of action of these agents illustrates different approaches being pursued in the discovery of novel treatments for seizures and epilepsy. For two of the compounds discussed in this report (azetukalner and soticlestat), clinical evidence of efficacy has already been obtained in a randomized placebo‐controlled adjunctive‐therapy trial. For the other compounds, adequately powered placebo‐controlled efficacy trials have not been completed to date.
01 Jun 2024·British Journal of Pharmacology
Radiprodil, a selective GluN2B negative allosteric modulator, rescues audiogenic seizures in mice carrying the GluN2A(N615S) mutation
Article
Author: Oberto, Alessandra ; Mirza, Naheed Rohman ; Sprengel, Rolf ; Muglia, Pierandrea ; Eva, Carola Eugenia ; Bertocchi, Ilaria ; Cifarelli, Lorenzo
Background and Purpose:
GRIN‐related disorders are neurodevelopmental disorders caused by mutations in N‐methyl‐D‐aspartate receptor (NMDAR) subunit genes. A large fraction of these mutations lead to a ‘gain of function’ (GoF) of the NMDAR. Patients present with a range of symptoms including epilepsy, intellectual disability, behavioural and motor. Controlling seizures is a significant unmet medical need in most patients with GRIN‐related disorders. Although several hundred GRIN mutations have been identified in humans, until recently none of the mouse models carrying Grin mutations/deletions showed an epileptic phenotype. The two recent exceptions both carry mutations of GluN2A. The aim of this study was to assess the efficacy of radiprodil, a selective negative allosteric modulator of GluN2B‐containing NMDARs, in counteracting audiogenic seizures (AGS) in a murine model carrying the GluN2A(N615S) homozygous mutation (Grin2aS/S mice).
Experimental Approach:
Grin2aS/S mice were acutely treated with radiprodil at different doses before the presentation of a high‐frequency acoustic stimulus commonly used for AGS induction.
Key Results:
Radiprodil significantly and dose‐dependently reduced the onset and severity of AGS in Grin2aS/S mice. Surprisingly, the results revealed a sex‐dependent difference in AGS susceptibility and in the dose‐dependent protection of radiprodil in the two genders. Specifically, radiprodil was more effective in female versus male mice.
Conclusion and Implications:
Overall, our data clearly show that radiprodil, a GluN2B selective negative allosteric modulator, may have the potential to control seizures in patients with GRIN2A GoF mutations. Further studies are warranted to better understand the sex‐dependent effects observed in this study.
13
News (Medical) associated with Radiprodil27 May 2025
GRIN also announces closing of $140 million Series D financing, including a $65 million strategic equity investment from Angelini Pharma and $75 million from existing investor Blackstone Life Sciences
Collaboration combines Angelini Pharma's global reach and focus on complex neurological disorders with GRIN's expertise and capabilities in developing and advancing precision therapeutics for neurodevelopmental disorders
Under terms of the collaboration, GRIN is to receive $50 million upfront, and is eligible to receive up to $520 million in milestones and tiered royalties in addition to shared development costs
GRIN will continue to lead global development and retains exclusive rights for radiprodil in the United States, Canada, and Mexico
Funding from both transactions will support ongoing operations including planned global pivotal Phase 3 trial for radiprodil in the treatment of GRIN-related neurodevelopmental disorder in 3Q 2025
NEW YORK and ROME, May 27, 2025 /PRNewswire/ -- GRIN Therapeutics, Inc., a leader in the development of therapies to treat serious neurodevelopmental disorders, and Angelini Pharma, part of the privately owned Angelini Industries, today announced a collaboration for the development and commercial rights outside of North America of GRIN Therapeutic's investigational drug radiprodil, currently being studied in multiple rare genetic epilepsies and neurodevelopmental disorders.
GRIN Therapeutics also announced the closing of its $140 million Series D financing with investment by Angelini Pharma and Blackstone Life Sciences. Together, the two transactions highlight a significant total near-term commitment of $115 million from Angelini Pharma, which includes a $65 million strategic equity investment and a $50 million upfront payment related to the collaboration. Existing GRIN Therapeutics investor Blackstone Life Sciences contributed $75 million to the Series D financing round. Jacopo Andreose, PhD, CEO of Angelini Pharma, will join GRIN's Board of Directors.
"We are very pleased to close this financing round and to welcome Angelini Pharma—an ideal partner whose engagement reflects the significant value we've built around the radiprodil program in a relatively short period," said Bruce Leuchter, MD, President & CEO of Neurvati Neurosciences and GRIN Therapeutics. "This strategic collaboration marks an important point of validation for GRIN Therapeutics, the clinical data generated to date, and the potential of radiprodil as the first approved treatment for patients with GRIN-related neurodevelopmental disorder (GRIN-NDD)—a population with urgent unmet need. We are also deeply grateful for the continued support and commitment of Blackstone Life Sciences, whose partnership has been instrumental in advancing our efforts. With this momentum, we are well-positioned to move radiprodil into pivotal trials and take an important step toward delivering a novel therapeutic option to patients and families."
"Our strategic collaboration with GRIN Therapeutics, including our participation in this Series D financing and in-licensing deal for radiprodil, reflects our dedication to advancing highly innovative treatments in brain health, building on our deep therapeutic expertise in neurology and psychiatry" said Jacopo Andreose, PhD, CEO of Angelini Pharma. "We see radiprodil as an opportunity to address the substantial unmet medical need of people living with GRIN-NDD and potentially other rare pediatric neurological diseases. We look forward to working closely with the team at GRIN Therapeutics to help bring this promising therapy to patients around the world."
"Angelini Pharma is a leading international pharmaceutical company and we are thrilled to have their backing, partnership and commitment to the further growth of GRIN Therapeutics and development of radiprodil," said Kiran Reddy, MD, Senior Managing Director, Blackstone Life Sciences. "The team's rapid progress with radiprodil—achieving multiple regulatory designations and advancing toward a pivotal Phase 3 trial— is very promising and today's milestone also validates the ability of Neurvati's model to efficiently develop high-impact neuroscience therapies."
Radiprodil is a targeted, selective, and potent negative allosteric modulator of the GluN2B subunit of the N-methyl-D-aspartate (NMDA) receptor. NMDA receptors are crucial for synaptic transmission, cognition and seizures. Several NDDs and epilepsy syndromes are associated with either genetic mutations or overactivation of NMDA receptors.
Radiprodil has received multiple regulatory designations, including Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with GRIN-NDD with gain-of-function (GoF) variants. Additionally, radiprodil has been granted FDA Orphan Drug designation, rare pediatric disease designation, European Medicines Agency (EMA) Priority Medicines (PRIME) designation, and a positive opinion for orphan designation from the EMA Committee for Medicinal Products for Human Use (CHMP) for the treatment of GRIN-NDD. The company remains on track to initiate a global, pivotal Phase 3 clinical trial for radiprodil in GRIN-NDD in the third quarter of 2025. Additionally, an ongoing open-label Phase 1b/2a study, known as the Astroscape trial, is evaluating radiprodil in patients with tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II.
Under the terms of the agreement, GRIN Therapeutics will continue to lead global development and retain exclusive rights for radiprodil in the United States, Canada, and Mexico. Angelini Pharma will receive exclusive rights to commercialize radiprodil in the rest of the world. GRIN Therapeutics will receive an upfront payment of $50 million, and the parties will share certain clinical development costs for radiprodil. Additionally, GRIN Therapeutics may receive up to an additional $520 million based on achieving certain development, regulatory and sales milestones. GRIN Therapeutics is also eligible to receive tiered royalties based on global sales as well as payments from any future sublicense transactions outside of Europe.
"Our strategic collaboration with Angelini Pharma shows how global partnerships can play an important role in advancing our business strategy at Neurvati, which is purpose-built to identify, advance, and unlock the potential of promising neuroscience assets through focused, mid-to-late stage development," said Dr. Leuchter, adding, "We are also very pleased to welcome Jacopo Andreose to our Board of Directors. His deep expertise in global drug development and commercialization will be a significant advantage for us as we progress radiprodil through Phase 3 development and prepare for potential regulatory approvals worldwide."
About Radiprodil
Radiprodil is an investigational, potent negative allosteric modulator selectively targeting the GluN2B subunit of the N-methyl-D-aspartate (NMDA) receptor, for the treatment of GRIN-related neurodevelopmental disorder (GRIN-NDD). It has been awarded Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations by the U.S. Food and Drug Administration as well as Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and a positive opinion for orphan designation from the EMA Committee for Medicinal Products for Human Use (CHMP). The planned global Phase 3 trial for radiprodil for GRIN-NDD will aim to evaluate the impact of a targeted treatment on core aspects of the disease, including seizures, behavioral abnormalities and functional outcomes. Radiprodil is also being developed for the treatment of tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II. The Astroscape trial (ClinicalTrials.gov identifier: NCT06392009) is an ongoing, open-label Phase 1b/2a clinical trial assessing the safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in patients with TSC or FCD type II.
About GRIN Therapeutics
GRIN Therapeutics is dedicated to the research and development of precision therapeutics for pediatric neurodevelopmental disorders with the goal of bringing hope to patients and caregivers. Late last year, GRIN Therapeutics reported promising topline data from a Phase 1b/2a clinical trial (the Honeycomb Trial, ClinicalTrials.gov NCT identifier: NCT05818943) evaluating radiprodil in GRIN-related neurodevelopmental disorder (GRIN-NDD) in patients with gain-of-function (GoF) variants, leading to the decision to advance to a global Phase 3 trial. The company has an additional ongoing clinical trial to evaluate radiprodil for the potential treatment of tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II. GRIN Therapeutics is an affiliate of Neurvati Neurosciences, a portfolio company of Blackstone Life Sciences. For more information, please visit
About Neurvati Neurosciences
Neurvati Neurosciences, a portfolio company of Blackstone Life Sciences, identifies and advances the development of high-potential drug candidates across the neuroscience landscape. Neurvati employs a collaborative model that establishes fit-for-purpose affiliate companies, aligning dedicated resources with long-term strategic capital to catalyze innovative treatment options in areas of unmet need. Neurvati's team of experienced operators and drug developers seeks opportunities to challenge current treatment paradigms and make a difference for patients suffering from a wide range of neurological and psychiatric disorders. For more information, please visit
About Angelini Pharma
Angelini Pharma is an international pharmaceutical company, part of the privately owned multi-business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit .
About Angelini Industries
Angelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over 2 billion euros, generated in the health, industrial technology, and consumer goods sectors. A targeted investment strategy for growth; constant commitment to research and development; deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates. To learn more visit .
About Blackstone Life Sciences
Blackstone Life Sciences is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines and medical technologies that improve patients' lives and currently has more than $12 billion in assets under management.
Corporate Contacts
GRIN Therapeutics
Elliott Ruiz, MBA
Senior Vice President, Finance & Operations
+1 201.674.5417
[email protected]
Angelini Pharma
Chiara Antoniucci
Global Head of Brand and Media Communications
+39 3477133926
[email protected]
SOURCE GRIN Therapeutics Inc.
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Phase 3Orphan DrugDrug ApprovalBreakthrough Therapy
27 May 2025
In a one-two punch, GRIN Therapeutics said Tuesday that it closed a $140-million series D round while simultaneously striking a licensing deal with Italy's Angelini Pharma that could generate more than $500 million in milestone payments tied to its experimental epilepsy treatment.The twin transactions centre on radiprodil, GRIN's candidate for GRIN-related neurodevelopmental disorder (GRIN-NDD), a spectrum of conditions that can include childhood-onset epilepsy, developmental delays, movement disorders and features of autism spectrum disorder. Angelini has committed $115 million in near-term funding across both deals — $65 million in equity and $50 million upfront for exclusive commercialisation rights outside North America.Aneglini is also on the hook for up to $520 million in development, regulatory and sales milestones, along with royalties and payments from any future sublicense transactions outside Europe. GRIN, which will share certain clinical development costs for the drug with Angelini, retains development leadership and North American rights for radiprodil.The medicine acts on the GluN2B subunit of NMDA receptors and has received multiple regulatory designations, including breakthrough therapy status from the FDA for treating GRIN-NDD seizures in patients with gain-of-function variants. The drug also holds an orphan drug designation in the US and a priority medicines designation from the European Medicines Agency."We see radiprodil as an opportunity to address the substantial unmet medical need of people living with GRIN-NDD and potentially other rare paediatric neurological diseases," commented Angelini CEO Jacopo Andreose.The financing will help GRIN launch a Phase III trial in the third quarter. The company reported positive topline data last year from a Phase Ib/IIa study where patients saw a median 86% drop in seizure frequency. GRIN is also studying radiprodil in tuberous sclerosis complex and focal cortical dysplasia through an ongoing Phase Ib/IIa trial.The deal is a boost for the New York-based epilepsy biotech, which operates as an affiliate of Neurvati Neurosciences, a neuroscience development platform backed by Blackstone Life Sciences — the other series D round investor, contributing $75 million.
Orphan DrugLicense out/inBreakthrough TherapyClinical ResultPhase 2
27 May 2025
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BeritK
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.
GRIN Therapeutics has two big reasons to smile today. A biotech developing therapies for rare epilepsies, GRIN has signed a duo of deals with Italy’s Angelini Pharma, raising $140 million in a series D plus more through a licensing deal that could be worth up to $570 million.
Angelini has gained outside–North America rights to radiprodil, which is under development for GRIN-related neurodevelopmental disorder (GRIN-NDD). The aptly named biotech also closed the series D, which includes a $65 million strategic equity investment from Angelini plus $75 million from existing investor Blackstone Life Sciences, according to a
Tuesday press release
.
The licensing deal includes $50 million upfront plus up to $520 million in milestones and royalties for development of radiprodil outside of Canada, the U.S. and Mexico. Angelini will take radiprodil worldwide, with GRIN receiving royalties on sales.
Altogether, the two deals mean $115 million from Angelini in the near term, according to the release.
Radiprodil is a negative allosteric modulator of the GluN2B subunit of the N-methyl-D-aspartate (NMDA) receptor, which is responsible for synaptic transmission, cognition and seizures. GRIN-NDDs are a group of genetic disorders caused by a change in one of the
GRIN
genes, which contain the code to create NMDA receptors. Symptoms of the disorders include developmental delay, seizures, autism, intellectual disability and more.
Funding from Angelini will help fuel a Phase III pivotal trial for radiprodil, which GRIN expects to begin in the third quarter of the year. The drug is also being tested in a Phase Ib/IIa study for patients with tuberous sclerosis complex (TSC) and focal cortical dysplasia (FCD) type II. The drug has been granted multiple FDA and European designations to advance its development, including breakthrough, orphan drug and rare pediatric disease.
Phase 3License out/inOrphan Drug
100 Deals associated with Radiprodil
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Seizures | Phase 2 | Australia | 10 Jul 2024 | |
| Seizures | Phase 2 | Belgium | 10 Jul 2024 | |
| Seizures | Phase 2 | Canada | 10 Jul 2024 | |
| Seizures | Phase 2 | Italy | 10 Jul 2024 | |
| Seizures | Phase 2 | Netherlands | 10 Jul 2024 | |
| Seizures | Phase 2 | Poland | 10 Jul 2024 | |
| Seizures | Phase 2 | Spain | 10 Jul 2024 | |
| Seizures | Phase 2 | United Kingdom | 10 Jul 2024 | |
| Spasms, Infantile | Phase 2 | France | 04 Dec 2017 | |
| Diabetic peripheral neuropathic pain | Phase 2 | United States | 01 Feb 2009 |
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Clinical Result
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1 | - | 10 | ivfolygvuo(egukkddemy) = wesmevikwj bbdtzmfbrx (dilytmobmq ) View more | - | 01 Feb 2019 |
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