Breathing brief, moderate bouts of low oxygen trigger (low oxygen therapy, LOT) spinal plasticity (the ability of the nervous system to strengthen neural pathways based on new experiences), and improve walking after spinal cord injury (SCI). The greatest improvements in walking ability occur when LOT is administered prior to skill-based walking practice (WALK). However, the enduring benefits of LOT on walking recovery may be undermined by the accumulation of LOT-induced increase in extracellular adenosine. The goal of the study is to understand the extent to which istradefylline (adenosine 2a receptor antagonist) may limit the competing mechanisms of adenosine on LOT-induced walking recovery following SCI.

Start Date01 Sep 2024

Sponsor / Collaborator

The Spaulding Rehabilitation Hospital Corp.

CTR20230645

/ RecruitingPhase 3

伊曲茶碱片用于改善左旋多巴治疗原发性帕金森病剂末现象的多中心、随机、双盲、安慰剂平行对照临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical trial of istradefylline tablets for improving the wearing-off phenomenon of levodopa in the treatment of primary Parkinson's disease

评价伊曲茶碱片用于改善左旋多巴治疗原发性帕金森病剂末现象的有效性和安全性

[Translation]

To evaluate the efficacy and safety of istradefylline tablets in improving the wearing-off phenomenon of levodopa in the treatment of primary Parkinson's disease

Start Date21 Jun 2023

Sponsor / Collaborator

Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.

NCT05885360

/ CompletedPhase 4IIT

Istradefylline Effect on Parkinson's Disease Tremor, Motor Symptoms and Non-motor Symptoms

This is an investigator-initiated trial. In this 6-month open label, single arm, exploratory pilot study, the investigator intends to enroll a pilot sample of 25 patients with Parkinson's disease who are being started on the novel FDA approved medication "Istradefylline'' as an add on therapy for management of their motor symptoms (based on the judgment of the movement disorders specialist, if patients are in sub-optimal management of their symptoms on maximum tolerable dose of their dopaminergic medications). The investigator will evaluate their motor symptoms before starting the new medication, including their MDS-UPDRS total and MDS-UPDRS-III scores.

Start Date20 Jan 2023

Sponsor / Collaborator

Georgetown University

[+1]

100 Clinical Results associated with Istradefylline

100 Translational Medicine associated with Istradefylline

100 Patents (Medical) associated with Istradefylline

443

Literatures (Medical) associated with Istradefylline

01 Apr 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

A2A receptor antagonist 4-(2-((6-Amino-9-ethyl-8-(furan-2-yl)-9H-purin-2-yl)amino)ethyl)phenol, a promising adenosine derivative for glioblastoma treatment

Article

Author: Devanesan, Sandhanasamy ; Marucci, Gabriella ; Spinaci, Andrea ; Volpini, Rosaria ; Alonso, Anxo Vila ; Konda Mani, Saravanan ; Smirnov, Aleksei ; Yli-Harja, Olli ; Francucci, Beatrice ; Buccioni, Michela ; Dal Ben, Diego ; AlSalhi, Mohamad S ; Kandhavelu, Meenakshisundaram ; Murugesan, Akshaya ; Cui, Chang ; Lambertucci, Catia

Adenosine, a pervasive signaling molecule mediated by its interaction with G-protein-coupled receptor subtypes, especially the A_2A adenosine receptor (A_2AAR), plays a crucial role in cancer treatment. Recently, A_2AAR targeting adenosine analogs have been proposed as a potential therapeutic target for cancer treatment. However, the molecules targeting A_2AAR and their mode of action in inhibiting glioblastoma cell progression remain unknown. We synthesized six adenosine derivatives substituted at the 9-, 2- and/or N^6- and/or 8- positions, and their anti-proliferative efficacy against the GBM cell lines LN229 and SNB19 was assessed. Molecular dynamic simulation integrated with experimental analyses, including cell cycle arrest, apoptosis assay, ligand binding assay, absorption, distribution, metabolism, excretion and toxicity (ADMET) profiling, PAMPA assay, and 3D spheroid analysis, were performed to identify the interaction efficacy of the potential derivative with A_2AAR and its ability to prevent GBM cell progression. The most potent A_2AAR derivative (ANR), 4-(2-((6-Amino-9-ethyl-8-(furan-2-yl)-9H-purin-2-yl)amino)ethyl)phenol (ANR 672) inhibits 5'-N-Ethylcarboxamidoadenosine (NECA)-induced cAMP validating the antagonistic property with higher cytotoxicity effect against GBM cells. ANR 672 showed higher affinity toward A_2AAR (K_i = 1.02 ± 0.06 nM) and exhibited significant IC₅₀ concentrations of ∼ 60-80 µM, than FDA approved drug istredefylline. The A_2AAR-ANR 672 interaction profile showed well-defined hydrogen bonds and hydrophobic contacts, indicating a typical binding mechanism inside the receptor pocket and a higher degree of conformational flexibility than the A_2AAR-Istradefylline complex. The antagonist effect of ANR 672 blocked the A_2AAR signaling pathway, leading to necrosis-mediated cell death and cell cycle arrest at the S-phase in both the GBM cells. ANR 672 treated 3D tumour spheroids analysis with real-time spheroid volume and cell proliferation analysis revealed the potential ability of ANR 672 against GBM cell growth. Drug-likeness assessments also showed favorable pharmacokinetic profiles for ANR 672. Further validation of blood-brain barrier crossing potential revealed that ANR 672 possesses moderate permeability. Our findings shed light on how ANR 672 exerts its GBM-suppressive effect through the interaction of A_2AAR. These preclinical results suggest that A_2AAR blockade could be a unique strategy for treating GBM.

01 Feb 2025·JOURNAL OF PHARMACEUTICAL SCIENCES

Advantages of the refined developability classification system in early discovery

Article

Author: Holm, René ; Dressman, Jennifer ; Beran, Kristian ; Sepassi, Kia ; Hermans, Eline

Rat pharmacokinetic studies are commonly utilized in early discovery to support absorption, distribution, metabolism, and excretion optimization of active pharmaceutical ingredients (APIs). The aim of this work was to compare exposures from fit-for-purpose oral suspension and solution formulations in rats to guidance provided by the refined Developability Classification System (rDCS) with respect to identifying potential limits to oral absorption, formulation strategy selection, and to optimize oral bioavailability (BA). This investigation utilized six diverse APIs covering a large range of biorelevant solubility, metabolic stability, and oral BA in rats. While results for our model compounds acetaminophen, voriconazole, fedratinib, lemborexant, and istradefylline indicated oral BA in rats was limited by first-pass metabolism, only the results for voxelotor indicated an oral absorption limitation by intestinal dissolution/solubility. The in vivo studies highlighted challenges and limitations often encountered in early discovery. The rDCS analysis provided a more differentiated developability risk assessment associated with oral solid dosage form development by incorporating compound-specific physicochemical attributes and human physiology without the need of preclinical data. The rDCS results were shown to align well with the clinical/marketed formulation strategies for the investigated APIs.

01 Feb 2025·British Journal of Pharmacology

A novel hypothesis‐generating computational workflow utilizing reverse pharmacophore mapping—A drug repurposing perspective of istradefylline towards major depressive disorder

Article

Author: Smith, Arnold Petrus ; van der Walt, Mietha Magdalena

Background and Purpose:

Drug repurposing (DR) offers a compelling alternative to traditional drug discovery's lengthy, resource‐intensive process. DR is the process of identifying alternative clinical applications for pre‐approved drugs as a low‐risk and low‐cost strategy. Computational approaches are crucial during the early hypothesis‐generating stage of DR. However, ‘large‐scale’ data retrieval remains a significant challenge. A computational workflow addressing such limitations might improve hypothesis generation, ultimately benefit patients and advance DR research.

Experimental Approach:

We introduce a novel computational workflow (combining free‐accessible computational platforms) to provide ‘proof‐of‐concept’ of the pre‐approved drug's suitability for repurposing. Three key phases are included: target fishing (via reverse pharmacophore mapping), target identification (via disease‐ and drug‐target pathway identification) and retrospective literature and drug‐like analysis (via in silico ADMET properties determination). Istradefylline is a Parkinson's disease‐approved drug with literature‐attributed antidepressant properties remaining unclear. Practically applied, istradefylline's antidepressant activity was assessed in the context of major depressive disorder (MDD).

Key Results:

Data mining aided by target identification resulted in istradefylline potentially representing a novel antidepressant drug class. Retrieved drug targets (KYNU, MAO‐B, ALOX12 and PLCB2) associated with selected MDD pathways (tryptophan metabolism and serotonergic synapse) generated a hypothesis that istradefylline increased extracellular 5‐HT levels (MAO‐B inhibition) and reduced inflammation (KYNU, ALOX12 and PLCB2 inhibition).

Conclusion and Implications:

The practically applied workflow's generated hypothesis aligns with known experimental data, validating the effectiveness of this novel computational workflow. It is a low‐risk and low‐cost DR computational tool providing a bird's‐eye view for exploring alternative clinical applications of pre‐approved drugs.

News (Medical) associated with Istradefylline

18 Aug 2024

·www.drugs.com

Enrollment Completed for Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease

HANGZHOU, China, Aug. 15, 2024. Vimgreen Pharmaceuticals, a science-driven pharmaceutical company focused on the modulation of adenosine signaling, announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC, a novel adenosine A2A receptor (A2AR) antagonist that also functions as an inverse A2AR agonist, for the treatment of early-to-mid stage Parkinson's disease. A total of 150 participants have been enrolled and randomized into one of three cohorts, a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group at a ratio of 1:1:1. The 12-week Phase 2 trial is a multicenter, randomized, placebo-controlled, double-blind study to investigate the safety and efficacy of VG081821 as monotherapy in early-to-mid stage PD patients. The primary endpoint was the difference of change from baseline in movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part III (motor symptoms) score between VG081821 and placebo over the 12 weeks of administration. For PD patients, current therapies are mainly dependent on dopamine replacement strategies with L-Dopa (top choice), dopamine agonists, MAO-B inhibitors and COMT inhibitors. These medicines either increase dopamine levels or mimic dopamine function. However, despite L-Dopa's efficacy in reducing the motor symptoms of PD, the onset of motor complications (wearing-off, ON–OFF, dyskinesia) is almost inevitable with long-term treatment. It is a well-known limit of the dopamine replacement therapy. In addition, the current therapies for PD are only symptomatic treatments. These therapies are unable to slow down the progression of PD. As an A2AR antagonist, which works non-dopaminergically, VG081821 has the potential to avoid, decrease or delay motor complications (wearing-off, ON–OFF, dyskinesia) if used early. What's special about VG081821 is that it is not only a highly potent A2A antagonist, but also a highly potent A2A receptor inverse agonist. More than a classical A2A antagonist, VG081821 may have extra therapeutic effect and greater efficacy on motor dysfunction in PD. Furthermore, VG081821 may provide not only symptomatic benefits, but also disease modifying benefits. VG081821 is expected to bring better treatment options and clinical benefits for PD patients. "In most previous trials of A2A antagonists for the treatment of Parkinson's Disease, A2A antagonists were used as an add-on treatment to alleviate off episodes in combination with L-Dopa for advanced PD patients. Although it has led to the approval of Istradefylline in US and Japan, it is not the best use of A2A antagonists for PD treatment," stated Sanxing Sun, President and Chief Executive Officer of Vimgreen. "VG081821 is to be used as monotherapy for improving movements in early-to-mid stage of PD. Later on, as the disease progresses, it can be used in combination with low doses of L-Dopa. This L-dopa sparing effect may minimize the problem of L-Dopa and prolong the quality of life of PD patients." It is known that A2AR gene expression in human peripheral blood mononuclear cells (PBMCs) are higher for PD patients. In the current Phase 2 trial of VG081821, the A2AR gene expression levels in PBMCs are to be analyzed. The potential correlation between drug efficacy and A2AR expression level may make VG081821 a precision medicine. The Phase 2 trial is to be completed in November. About VG081821AC VG081821AC/VG081821 is a potent, selective antagonist of adenosine A2A receptor (A2AR) developed by Vimgreen. Adenosine A2A receptors are distributed across basal ganglia, in particular in the striatum, and are believed to be involved in the regulation of motor functions. This makes A2AR an attractive non-dopaminergic target to treat the disease. VG081821 is an innovative A2AR antagonist that is not only a highly potent A2A antagonist, but also a highly potent A2A receptor inverse agonist. It is expected to bring better treatment options and clinical benefits for PD patients. About Vimgreen Pharmaceuticals Vimgreen is a science-driven pharmaceutical company located in the beautiful city of Hangzhou, China. At Vimgreen, the research programs are focused on the modulation of adenosine signaling. Adenosine is a major signaling molecule that is involved in a variety of critical physiological processes via activation of the adenosine receptors (A1, A2A, A2B or A3), including regulation of the nervous system, immune response, vascular function, and metabolism. In recent years, substantial progress has been made to understand the role of adenosine signaling in different pathologies during disease progression. These efforts have identified therapeutic possibilities for the treatment of various diseases, by either replenishing or inhibiting relevant adenosine signaling pathways. Currently Vimgreen has two compounds in clinical development. One is VG081821, an A2AR antagonist for the treatment of Parkinson's Disease. The other compound is VG290131, an A3 agonist for the treatment of NASH. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "may", "will", "should", "potential" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with Vimgreen's ability to execute on its commercial strategy. Forward-looking statements speak only as of the date when made. Vimgreen does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. SOURCE Vimgreen Pharmaceuticals Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 2Clinical Result

15 Aug 2024

·www.prnewswire.com

Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease

HANGZHOU, China, Aug. 15, 2024 /PRNewswire/ -- Vimgreen Pharmaceuticals, a science-driven pharmaceutical company focused on the modulation of adenosine signaling, announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC, a novel adenosine A2A receptor (A2AR) antagonist that also functions as an inverse A2AR agonist, for the treatment of early-to-mid stage Parkinson's disease. A total of 150 participants have been enrolled and randomized into one of three cohorts, a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group at a ratio of 1:1:1. The 12-week Phase 2 trial is a multicenter, randomized, placebo-controlled, double-blind study to investigate the safety and efficacy of VG081821 as monotherapy in early-to-mid stage PD patients. The primary endpoint was the difference of change from baseline in movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) part III (motor symptoms) score between VG081821 and placebo over the 12 weeks of administration. For PD patients, current therapies are mainly dependent on dopamine replacement strategies with L-Dopa (top choice), dopamine agonists, MAO-B inhibitors and COMT inhibitors. These medicines either increase dopamine levels or mimic dopamine function. However, despite L-Dopa's efficacy in reducing the motor symptoms of PD, the onset of motor complications (wearing-off, ON–OFF, dyskinesia) is almost inevitable with long-term treatment. It is a well-known limit of the dopamine replacement therapy. In addition, the current therapies for PD are only symptomatic treatments. These therapies are unable to slow down the progression of PD. As an A2AR antagonist, which works non-dopaminergically, VG081821 has the potential to avoid, decrease or delay motor complications (wearing-off, ON–OFF, dyskinesia) if used early. What's special about VG081821 is that it is not only a highly potent A2A antagonist, but also a highly potent A2A receptor inverse agonist. More than a classical A2A antagonist, VG081821 may have extra therapeutic effect and greater efficacy on motor dysfunction in PD. Furthermore, VG081821 may provide not only symptomatic benefits, but also disease modifying benefits. VG081821 is expected to bring better treatment options and clinical benefits for PD patients. "In most previous trials of A2A antagonists for the treatment of Parkinson's Disease, A2A antagonists were used as an add-on treatment to alleviate off episodes in combination with L-Dopa for advanced PD patients. Although it has led to the approval of Istradefylline in US and Japan, it is not the best use of A2A antagonists for PD treatment," stated Sanxing Sun, President and Chief Executive Officer of Vimgreen. "VG081821 is to be used as monotherapy for improving movements in early-to-mid stage of PD. Later on, as the disease progresses, it can be used in combination with low doses of L-Dopa. This L-dopa sparing effect may minimize the problem of L-Dopa and prolong the quality of life of PD patients." It is known that A2AR gene expression in human peripheral blood mononuclear cells (PBMCs) are higher for PD patients. In the current Phase 2 trial of VG081821, the A2AR gene expression levels in PBMCs are to be analyzed. The potential correlation between drug efficacy and A2AR expression level may make VG081821 a precision medicine. The Phase 2 trial is to be completed in November. About VG081821AC VG081821AC/VG081821 is a potent, selective antagonist of adenosine A2A receptor (A2AR) developed by Vimgreen. Adenosine A2A receptors are distributed across basal ganglia, in particular in the striatum, and are believed to be involved in the regulation of motor functions. This makes A2AR an attractive non-dopaminergic target to treat the disease. VG081821 is an innovative A2AR antagonist that is not only a highly potent A2A antagonist, but also a highly potent A2A receptor inverse agonist. It is expected to bring better treatment options and clinical benefits for PD patients. About Vimgreen Pharmaceuticals Vimgreen is a science-driven pharmaceutical company located in the beautiful city of Hangzhou, China. At Vimgreen, the research programs are focused on the modulation of adenosine signaling. Adenosine is a major signaling molecule that is involved in a variety of critical physiological processes via activation of the adenosine receptors (A1, A2A, A2B or A3), including regulation of the nervous system, immune response, vascular function, and metabolism. In recent years, substantial progress has been made to understand the role of adenosine signaling in different pathologies during disease progression. These efforts have identified therapeutic possibilities for the treatment of various diseases, by either replenishing or inhibiting relevant adenosine signaling pathways. Currently Vimgreen has two compounds in clinical development. One is VG081821, an A2AR antagonist for the treatment of Parkinson's Disease. The other compound is VG290131, an A3 agonist for the treatment of NASH. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "may", "will", "should", "potential" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with Vimgreen's ability to execute on its commercial strategy. Forward-looking statements speak only as of the date when made. Vimgreen does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. SOURCE Vimgreen Pharmaceuticals

Phase 2

12 Apr 2024

·www.prnewswire.com

Kyowa Kirin to Present a Safety Meta-Analysis of NOURIANZ® (istradefylline) and Other Parkinson's Disease Add-On Therapies

Findings to be presented at 2024 American Academy of Neurology annual conference between April 13-18 in Denver, CO PRINCETON, N.J., April 12, 2024 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, will announce findings from an updated systematic literature review (SLR) and meta-analysis comparing the safety of NOURIANZ® (istradefylline) in relation to other levodopa adjunctive therapies for patients with Parkinson's Disease (PD).1,2 NOURIANZ is an adenosine receptor antagonist used with levodopa/carbidopa to treat adults with PD experiencing "off" episodes, the return of Parkinson's symptoms between medication doses. The findings will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, during a poster presentation on Monday, April 15, from 5:30 – 6:30 PM MDT. Parkinson's disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement, and postural instability. Within 5 years of starting levodopa/carbidopa treatment, half of people living with PD begin to experience "off" time, including problems with movement.3 Adjunctive therapies may be used to treat these episodes but are often hampered by safety and tolerability issues that limit their clinical utility.1 "With the growing landscape of adjunctive therapies for Parkinson's disease, it is important for physicians to have data that demonstrates the relative risk profiles of these treatment options," said lead author Yasar Torres-Yaghi, MD, MedStar Georgetown University Hospital. "These data provide useful information on safety and tolerability of these therapies, an important factor for physicians when choosing an appropriate adjunctive therapy for patients experiencing "off" episodes." About the Study Researchers updated a previously published SLR with an additional 20 randomized controlled trials from Jan 1, 2010, to April 15, 2019, evaluating adjunctive therapies in patients with PD. The study analyzed data from a total of 57 randomized clinical trials involving 11,517 patients. Interventions included COMT inhibitors, monoamine oxidase type B (MAO-B) inhibitors, dopamine agonists (DAs), istradefylline, and amantadine ER. A pair-wise meta-analysis was conducted to calculate summary odds ratios (OR) and 95% confidence intervals (CI). Bucher indirect comparisons were used to generate estimates of relative safety, and information on study design, eligibility criteria, and baseline characteristics were extracted for heterogeneity assessment. About NOURIANZ® NOURIANZ is an adenosine receptor antagonist indicated as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. It is not known if istradefylline is safe and effective in children.4 Important Safety Information Warnings and Precautions Dyskinesia: NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In clinical trials, 1% of patients treated with either NOURIANZ 20 mg or 40 mg discontinued treatment because of dyskinesia, compared to 0% for placebo. Hallucinations / Psychotic Behavior: Because of the potential risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with NOURIANZ. Consider dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors while taking NOURIANZ. Impulse Control / Compulsive Behaviors: Patients treated with NOURIANZ and one or more medication(s) for the treatment of Parkinson's disease (including levodopa) may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges. In clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control disorder, compared to no patient on NOURIANZ 20 mg or placebo. DRUG INTERACTIONS The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once daily. Avoid use of NOURIANZ with strong CYP3A4 inducers. SPECIAL POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ADVERSE REACTIONS The most common adverse reactions with an incidence ≥5% and occurring more frequently than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%), constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%), and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively. You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or . Please click to see full Prescribing Information for Nourianz. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, focusing on bone/mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: kkna.kyowakirin.com References Torres-Yaghi Y., Qian, J. et al. (2024). Comparative Safety of Istradefylline Among Parkinson's Disease Adjunctive Therapies: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Data presented at the 2024 American Academy of Neurology Annual Meeting, April 13-18, 2024, Denver, CO. Stowe R et al. Movement disorders. 2011;26(4):587-98 Hickey, P., & Stacy, M. (2011). Available and Emerging Treatments for Parkinson's Disease: A Review. Drug Design, Development and Therapy, 5, 241-254. doi:10.2147/DDDT.S11836 NOURIANZ. Prescribing Information. Kyowa Kirin Inc. Princeton, NJ. SOURCE Kyowa Kirin

Clinical ResultClinical Study

100 Deals associated with Istradefylline

External Link

KEGG	Wiki	ATC	Drug Bank
D04641	Istradefylline	N04B	DB11757

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Parkinson Disease	Japan	Kyowa Kirin Co., Ltd.	25 Mar 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary Parkinson's disease	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	28 Feb 2019
Cognitive Dysfunction	Phase 2	United States	Kyowa Kirin, Inc.	18 Jul 2022
Drug abuse	Phase 1	United States	Kyowa Kirin Co., Ltd.	01 Jan 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P5-3.017 (AAN2024)	Not Applicable	Parkinson Disease	-	Istradefylline 40mg	rtqlydfozg(rqpvelqdje) = The odds of hallucinations were significantly higher for amantadine vs. istradefylline at 40 and 20mg hbyskdaraa (yerqdujkik ) View more	Positive	09 Apr 2024
				Istradefylline 20mg
MDS2023	Not Applicable	Dystonia \| Parkinson Disease	-	Istradefylline	nyjounofcy(hwnyfavsly) = govgijottm nzoirhyplm (fezodhqsio )	-	27 Aug 2023
				Istradefylline	nyjounofcy(hwnyfavsly) = uxriqnuber nzoirhyplm (fezodhqsio )
MDS2023	Phase 3	-	214	Istradefylline	jflwctcpda(uiynxtqfid) = imxvyepull cnllpxbkcf (ipzdeqqouq )	Positive	27 Aug 2023
				No Istradefylline	jflwctcpda(uiynxtqfid) = znzqgbapby cnllpxbkcf (ipzdeqqouq )
ISTRA ADJUST PD (MDS2022)	Not Applicable	Parkinson Disease	114	Istradefylline	vbforikvsj(sgembmsykk) = tuahblqhwk mvixcarapt (vopetkrcds )	-	15 Sep 2022
				Control (no Istradefylline)	vbforikvsj(sgembmsykk) = qwtolzajxe mvixcarapt (vopetkrcds )
P1-1.Virtual (AAN2022)	Not Applicable	Parkinson Disease	-	Istradefylline 20 mg	mcdbsjgvxb(givvzfunya) = srnjibfonz acivyvpmef (nyxftkdzhx ) View more	Positive	03 May 2022
				Istradefylline 40 mg	ihqumokjzg(dqmurbxmlr) = ucxsgqbuup jyicdfqmiy (xpzltdwhud )
MDS2021	Not Applicable	Parkinson Disease fasting glucose \| HbA1c \| insulin ... View more	-	IST-LD combination group	knbtljgqwp(vhqiwjtgtj) = yjjobkfpjr jjtmagbtlv (sehbosirta ) View more	-	17 Sep 2021
				LD group	knbtljgqwp(vhqiwjtgtj) = meeygmfnln jjtmagbtlv (sehbosirta ) View more
NCT01968031 (KW-6002, CTgov)	Phase 3	Parkinson Disease	613	Placebo (Placebo)	wgnvdyffel(kuygcbtfhx) = iogyrntzle qqnsenfoje (wljtvovjfd, hycwawbfoy - iteoxrdzpi) View more	-	20 Nov 2020
				Placebo+Istradefylline 20 mg (Istradefylline 20 mg/Day)	wgnvdyffel(kuygcbtfhx) = qfsdvqonib qqnsenfoje (wljtvovjfd, azzeujdmcr - kcbxaelkzh) View more
ANA2020	Phase 3	-	1,143	Istradefylline 20mg/day	zyokxgiqdm(tdavpzueqz) = wmvqonmvyq nkxsiletra (cefqbjkjyh, -1.10 to -0.40) View more	Positive	25 Sep 2020
				Istradefylline 40mg/day	zyokxgiqdm(tdavpzueqz) = pduuiugxyw nkxsiletra (cefqbjkjyh, -1.17 to -0.47) View more
ANA2020	Phase 2/3	-	1,160	Istradefylline 20 mg/day	uyuzqtcqvf(rksfbcxstn) = The most common TEAE was dyskinesia (20 mg/day, 14.6%; 40 mg/day, 16.7%; placebo, 7.5%) wjzmnvuwwu (okfwjuzaqz ) View more	Positive	25 Sep 2020
				Istradefylline 40 mg/day
MDS2020	Not Applicable	-	31	Istradefylline 20 mg/day	kyjaqlsvrz(mgszbhjysh) = 2 (6.5%) patients ouckghqkhl (acayduqvnv ) View more	-	12 Sep 2020
				Placebo

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis