Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors), D2 receptor antagonists(Dopamine D2 receptor antagonists), ERK1 inhibitors(Extracellular-signal-regulated kinase1 inhibitors)

Therapeutic Areas

NeoplasmsNervous System DiseasesOther Diseases+ [5]

Active Indication

Diffuse midline glioma, point mutation K27M in histone H3GliomaDiffuse Intrinsic Pontine Glioma+ [15]

Inactive Indication

Advanced cancerAdvanced Colorectal AdenocarcinomaAdvanced Endometrial Carcinoma+ [22]

Originator Organization

Active Organization

+ [5]

Inactive Organization

Icahn School of Medicine at Mount SinaiSanjiu Healthy World Co., Ltd.Jonsson Comprehensive Cancer Center

+ [1]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationPriority Review (US), Fast Track (US), Orphan Drug (EU), Orphan Drug (AU), Rare Pediatric Disease (US)

Structure/Sequence

Molecular FormulaC24H26N4O

InChIKeyVLULRUCCHYVXOH-UHFFFAOYSA-N

CAS Registry1616632-77-9

Clinical Trials associated with Dordaviprone

NCT06012929

/ SuspendedPhase 2IIT

A Pilot Study, Open-Label Study of ONC201 for Refractory Meningioma

The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment.
The primary goals of this study are:
1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor
2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

Start Date01 Dec 2025

Sponsor / Collaborator

University of Nebraska

[+1]

NCT05630794

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of ONC201 for Chemoprevention of Colorectal Cancer

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Start Date30 Mar 2025

Sponsor / Collaborator

National Cancer Institute

NCT04629209

/ WithdrawnPhase 2IIT

A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma

This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.

Start Date28 Jun 2024

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

[+1]

100 Clinical Results associated with Dordaviprone

100 Translational Medicine associated with Dordaviprone

100 Patents (Medical) associated with Dordaviprone

221

Literatures (Medical) associated with Dordaviprone

16 Feb 2025·ChemMedChem

Development of Small Molecular Hyper‐activators of Human Caseinolytic Peptidase P (hClpP) with a [1,8]‐naphthyridinone Scaffold as Novel Anti‐cancer Agents

Article

Author: Li, Zhilong ; Jiang, Jinxin ; Sun, Haiying ; Fu, Yuantao ; Xie, Guangjun ; Xiao, Yibei ; Tan, Rongliang ; Li, Tong ; Yuan, Yinan

Abstract:

Based on a clinical staged small molecular hClpP activator ONC201, a class of novel hClpP agonists with a [1,8]naphthyridinone scaffold was designed, synthesized and evaluated in a series of biochemical and biological assays. Mechanism studies for the representative compound F20 indicated that it can potently bind to and activate hClpP, efficiently promote the degradation of hClpP substrates, robustly induce ATF4/CHOP regulated integrated stress responses, strongly inhibit cell growth and effectively induce apoptosis in a subset of cancer cell lines. F20 showed good PK profiles when dosed by intravenous injection and exhibited moderate oral bioavailability in mice.

04 Feb 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Serine phosphorylation facilitates protein degradation by the human mitochondrial ClpXP protease

Article

Author: Schimmer, Aaron D. ; Yudin, Andrei K. ; Privé, Gilbert G. ; Keszei, Alexander F. A. ; Tcheng, Matthew ; Hurren, Rose ; Feng, Yue ; Trudel, Vincent ; Jitkova, Yulia ; Schultz, Matthew ; Lees, Kaitlin ; Upadhyay, Rahul ; Yan, Yongran ; Pomroy, Neil C. ; Vahidi, Siavash ; Gronda, Marcela ; Kenney, Tristan M. G. ; Mancini, Ross S. ; Mazhab-Jafari, Mohammad T. ; St-Germain, Jonathan ; Penn, Linda Z. ; Raught, Brian ; Reed, Mark A. ; Goncalves, Monica M. ; Currie, S. Quinn W. ; Soriano, Kaylen ; Arrowsmith, Cheryl H. ; Sarathy, Chaitra

ClpXP is a two-component mitochondrial matrix protease. The caseinolytic mitochondrial matrix peptidase chaperone subunit X (ClpX) recognizes and translocates protein substrates into the degradation chamber of the caseinolytic protease P (ClpP) for proteolysis. ClpXP degrades damaged respiratory chain proteins and is necessary for cancer cell survival. Despite the critical role of ClpXP in mitochondrial protein quality control, the specific degrons, or modifications that tag substrate proteins for degradation by human ClpXP, are still unknown. We demonstrated that phosphorylated serine (pSer) targets substrates to ClpX and facilitates their degradation by ClpXP in biochemical assays. In contrast, ClpP hyperactivated by the small-molecule drug ONC201 lost the preference for phosphorylated substrates. Hydrogen deuterium exchange mass spectrometry combined with biochemical assays showed that pSer binds the RKL loop of ClpX. ClpX variants with substitutions in the RKL loop failed to recognize phosphorylated substrates. In intact cells, ClpXP also preferentially degraded substrates with pSer. Moreover, ClpX substrates with the pSer were selectively found in aggregated mitochondrial proteins. Our work uncovers a mechanism for substrate recognition by ClpXP, with implications for targeting acute myeloid leukemia and other disorders involving ClpXP dysfunction.

01 Feb 2025·EUROPEAN JOURNAL OF CANCER

Real life data of ONC201 (dordaviprone) in pediatric and adult H3K27-altered recurrent diffuse midline glioma: Results of an international academia-driven compassionate use program

Article

Author: Brunel, L ; Yoldjian, I ; Grill, J ; Sanson, M ; Vauleon, E ; Capra, M ; Vassal, G ; Rieutord, A ; Epaillard, N ; Hezam, I ; Lemos, F ; Vignes, M ; Gandemer, V ; Salomon, V ; Touat, M ; Duperray, F ; De Carli, E ; Annereau, M ; Bourdeaut, F ; Guyon, D ; Denis, L ; Di Carlo, D ; Baiao, X ; Dumont, S ; Jacobs, S ; Abbou, S

INTRODUCTION:

H3K27-altered diffuse midline gliomas (DMG) have limited therapeutic options and a very poor prognosis. Encouraging responses were observed in early clinical trials with ONC201. As ONC201 was unavailable in Europe, a compassionate use program supported by the French Authorities was launched for patients at progression after standard of care radiotherapy.

METHODS:

This program was developed by the French Society of Pediatric Oncology (SFCE) and Association des Neuro-Oncologues d'Expression Française in collaboration with the French National Agency For Medicines and Health Products Safety and Parents Associations.

RESULTS:

174 patients (102 children, 72 adults) from 14 countries were treated from November 2021 to August 2023 at Gustave Roussy Institut (Villejuif, France). 37 % received a second course of irradiation at the time of relapse. Median duration of treatment was 57 days or 1,9 months (mo) (range 1-456 days). Median OS since diagnosis for the whole cohort was 466 days or 15,5 mo (112-2612 days); 426 or 14,2 mo (112-2612 days) and 590 or 19,6 mo (range 160-1881) for children and adults, respectively (p = 0.001). Median OS after ONC201 start was 143 days or 4,7 mo (1-711 days) for the whole cohort. Univariate and multivariable analysis identified site (thalamus) and age (older) as favorable prognostic factors. Reirradiation was associated with significantly longer survival after ONC201 start only in children.

CONCLUSION:

While the efficacy of ONC201 needs validation in a controlled randomized clinical trial, our real-life data support a better outcome for patients with thalamic tumors treated with ONC201. We demonstrated furthermore the feasibility of a successful academia-driven compassionate use program.

News (Medical) associated with Dordaviprone

18 Feb 2025

·ir.chimerix.com

Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma

Potential First Approval for Patients with Recurrent H3 K27M-mutant Diffuse Glioma PDUFA Target Action Date of August 18, 2025 No Advisory Committee Meeting Currently Planned to Discuss Application DURHAM, N.C. , Feb. 18, 2025 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 18, 2025 . The FDA does not currently plan to hold an advisory committee meeting to discuss the application. “This significant milestone brings us one step closer to our goal of accelerating access to the first medicine specific to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma," said Mike Andriole , Chief Executive Officer of Chimerix . "Patients with this form of high-grade glioma face a very difficult prognosis with few treatment options beyond palliative care. Our team is working expeditiously with FDA to facilitate their review as we simultaneously prepare for a potential commercial launch in order to ensure rapid availability to patients in need." Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and has applied for a Rare Pediatric Disease Priority Review Voucher (PRV) in the NDA submission. The application remains eligible for this PRV by virtue of its Priority Review status. Dordaviprone also has Fast-Track Designation in the United States and Orphan Drug Designation in the United States , Europe and Australia . About DordaviproneDordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). About Chimerix Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things: the possible regulatory path forward for dordaviprone, including the timing and consequences of accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; the timeline of related discussions with the FDA; the initial potential PDUFA timing; the timing of the U.S. commercial launch; and the expected impact of dordaviprone on patients. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks related to the ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; completion and outcome of the Phase 3 ACTION study of dordaviprone; risks associated with market acceptance; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; and additional risks set forth in the Company’s filings with the Securities and Exchange Commission . These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. CONTACT:Investor ContactWill O’ConnorStern Investor Relations212-362-1200 Media Contact Dana Davis Steelwire dana@steelwire.co Source: Chimerix, Inc.

Priority ReviewNDAFast TrackOrphan DrugPhase 1

09 Dec 2024

·www.globenewswire.com

Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

Potential Approval in Q3 2025 in Recurrent H3 K27M-Mutant Diffuse Glioma Submission Plan Follows Productive and Collaborative Pre-NDA Interactions with FDA Company to Host Conference Call on Tuesday, December 10 at 8:30 AM ET DURHAM, N.C., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that, following extensive dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end. “We expect that, if approved, dordaviprone will fundamentally change the treatment landscape for patients suffering from this lethal form of brain cancer who have extremely limited treatment options. We have worked collaboratively with the U.S. FDA, disease experts and patient advocates throughout the year to potentially accelerate access to dordaviprone for this patient community,” said Mike Andriole, Chief Executive Officer of Chimerix. “In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted.” “As a pediatric oncologist, this program is particularly meaningful given the impact a potential approval would have on children and young adults devastated by this disease. We are confident that the data generated to date could support an accelerated approval for this urgent unmet medical need,” said Allen Melemed M.D., Chief Medical Officer of Chimerix. “H3 K27M mutant gliomas are extremely aggressive and affect over 2,000 patients annually in the United States. If successful, dordaviprone would be the first FDA-approved therapy for this lethal disease, as well as one of the first molecularly defined approvals for any high-grade glioma.” The following recent program milestones and additional supportive data were extensively discussed with the FDA and will be included in the NDA: Substantial enrollment of the Phase 3 ACTION studyPhase 2 objective response rate of the 50-patient primary efficacy analysis assessed by blinded independent central review (BICR) as the primary basis of efficacy in the NDASeveral response assessments, including the most contemporary response assessment criteria for gliomas, Response Assessment in Neuro-Oncology 2.0 (RANO 2.0), under which dordaviprone demonstrated an objective response rate of 28%, a median duration of response of 10.4 months and a median time to response of 4.6 months Additional clinical data sets and patient narratives supportive of the primary efficacy analysisClinical and nonclinical demonstration of dordaviprone-driven reversal of the central hallmark of H3 K27M-mutant glioma, H3K27 trimethyl lossComprehensive safety database of glioma patients and healthy volunteers that supports a favorable benefit/risk profileComprehensive clinical pharmacology and chemistry, manufacturing, and controls (CMC) studies Chimerix will request Priority Review for the NDA. If granted, the resulting six-month FDA review period is expected to result in a potential initial Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and is eligible to apply for a Rare Pediatric Disease Priority Review Voucher (PRV). Chimerix intends to apply for a Rare Pediatric Disease PRV in the upcoming NDA submission. Conference Call and WebcastChimerix will host a conference call and live audio webcast on Tuesday, December 10 at 8:30 a.m. ET. To access the live conference call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) at least five minutes prior to the start time and refer to conference ID 8870160. A live audio webcast of the call will also be available on the Investors section of Chimerix’s website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, dordaviprone, is in development for H3 K27M-mutant glioma. The Company is conducting Phase 1 dose escalation studies of ONC206 to evaluate safety and PK data. About DordaviproneDordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things: the possible regulatory path forward for dordaviprone, including the potential to seek accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers and approval for marketing authorization; timing and consequences of an NDA submission to FDA; FDA’s acceptance for filings; the timeline of related discussions with the FDA; the initial potential PDUFA timing; the potential commercial opportunity; the ability of dordaviprone to attain significant market acceptance among disease experts, patient advocates and their patients; and the expected impact of dordaviprone on patients. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks related to the ability to obtain and maintain accelerated approval, Priority Review, rare pediatric disease Priority Review vouchers, and approval for marketing authorization; uncertainty on the response of regulators to including additional supportive data to be submitted in the NDA filing, including RANO 2.0 assessments, and uncertainty with respect to the initial potential PDUFA timing; risks related to the timing, completion and outcome of the Phase 3 ACTION study of dordaviprone; risks associated with market acceptance; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; risks related to the clinical development of our clinical candidates; and additional risks set forth in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. CONTACT: Will O’ConnorStern Investor Relations212-362-1200 Dana DavisSteelwire Public Relationsdana@steelwire.co

Priority ReviewNDAPhase 3Phase 1

14 Nov 2024

·www.globenewswire.com

Chimerix Announces Updated Phase 2 Response Assessment of Dordaviprone in Recurrent H3 K27M Glioma at the 2024 SNO Meeting

Nov. 11, 2024 -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced upcoming presentations at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, which will be held in Houston, TX from November 21 – 24, 2024. “We are excited to provide an updated assessment of objective response to dordaviprone previously reported in the blinded independent central review (BICR) cohort1 in recurrent H3 K27M-mutant diffuse midline glioma using Response Assessment in Neuro-Oncology (RANO) 2.02, the most recently established criteria for this disease. This analysis demonstrates an overall response rate of 28.0%, a median time to response of 4.6 months plus a median duration of response of 10.4 months,” said Allen Melemed, MD, Chief Medical Officer at Chimerix. We expect to include the updated RANO 2.0 results in our planned upcoming New Drug Application to Australian regulators.” “RANO 2.0 is a recently established response assessment criteria for gliomas that supersedes prior versions such as RANO-HGG and RANO-LGG. RANO 2.0 incorporates an integrated quantitative assessment of both enhancing and non-enhancing disease that were not adequately assessed by prior criteria. In addition, it includes minor responses, which in certain regions of the brain, such as midline structures, have disproportionate clinical benefit. This benefit often includes meaningful improvement in neurological symptoms and quality of life outcomes,” said Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute. Details for the RANO 2.0 presentation as well as other pipeline presentations at SNO are as follows: Title: Response by RANO 2.0 criteria in ONC201 (dordaviprone)-treated patients with recurrent H3 K27M-mutant diffuse midline glioma Abstract Code: CTNI-54 Session Date and Time: Friday, November 22, 2024, from 7:30-9:30 PM Location: The George R. Brown Convention Center, Hall B3 Title: Allosteric mitochondrial ClpP agonist ONC206 alters stress response, metabolic and epigenetic profiles to elicit anti-cancer efficacy in high-grade gliomas Abstract Code: EXTH-37 Session Date and Time: Friday, November 22, 2024, from 7:30-9:30 PM Location: The George R. Brown Convention Center, Hall B3 Title: Safety of ONC201 treatment in patients with previously treated H3 K27M-mutant glioma: results from ONC028, an ongoing compassionate use program Abstract Code: NCOG-07 Abstract Session: CNS Rare Tumors Presentation Date and Time: Saturday, November 23, 2024, from 10:45am-12:15pm Title: Early reduction in MRI diffusion apparent diffusion coefficient (ADC) strongly predicts long term response to ONC201 therapy in patient with H3K27M-DMG Abstract Code: NIMG-29 Abstract Session: Pediatrics II Presentation Date and Time: Saturday, November 23, 2024, from 10:45am-12:15pm Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma. Arrillaga-Romany, et al, Journal of Clinical Oncology, Feb 2024 Wen, et al, Journal of Clinical Oncology, Sept 2023 The content above comes from the network. if any infringement, please contact us to modify.

ASCO

100 Deals associated with Dordaviprone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14844

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diffuse midline glioma, point mutation K27M in histone H3	NDA/BLA	US	Chimerix, Inc.	30 Dec 2024
Glioma	NDA/BLA	AU	Chimerix, Inc.	07 Nov 2024
Diffuse Intrinsic Pontine Glioma	Phase 3	DK	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	FR	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	ES	Chimerix, Inc.	29 Sep 2022
Diffuse Intrinsic Pontine Glioma	Phase 3	SE	Chimerix, Inc.	29 Sep 2022
Meningioma	Phase 2	US	Chimerix, Inc.	01 Dec 2025
Recurrent Glioma	Phase 2	US	National Institute of Neurological Disorders & Stroke	20 Oct 2021
Recurrent Glioma	Phase 2	AU	National Institute of Neurological Disorders & Stroke	20 Oct 2021
Recurrent Glioma	Phase 2	IL	National Institute of Neurological Disorders & Stroke	20 Oct 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03034200 (CTgov)	Phase 2	Neuroendocrine Tumors \| Pheochromocytoma	30	ONC201 (Arm A: Metastatic PC-PG)	uznhcsotkf(ijmxripqsv) = dfgkhuoznn hyqawcffim (ejytwfnnot, vxetnaiffa - zweoxqquzq) View more	-	26 Nov 2024
				ONC201 (Arm B: Other NETs)	uznhcsotkf(ijmxripqsv) = mpodihswfn hyqawcffim (ejytwfnnot, hdztzcwzas - xcqlpaneog) View more
NCT05580562 (ACTION, ASTRO2024)	Phase 3	Diffuse midline glioma, point mutation K27M in histone H3	50	ONC201	tfwoyuwhus(poovvtlrpv) = blxeeynyqe bhlxdiadpr (gtomzbhkgu )	Positive	01 Oct 2024
				Standard Radiotherapy Dosing Regimens	tfwoyuwhus(poovvtlrpv) = vwcgfadeyh bhlxdiadpr (gtomzbhkgu )
NCT02863991 (CTgov)	Phase 1/2	Relapse multiple myeloma	17	ONC201+Dexamethasone (Phase 1: 375 mg ONC201 + 20 mg Dexamethasone)	sgdekxxltp(rpvlbgcdox) = kmrsxtkmji bbpunmpwyb (mjnjkqmuta, xpkumljcgz - aaxdwzndsu) View more	-	03 Jul 2024
				ONC201+Dexamethasone (Phase 2: 625 mg ONC201 + 20 mg Dexamethasone)	sgdekxxltp(rpvlbgcdox) = znnsujdisy bbpunmpwyb (mjnjkqmuta, vbymgcwsoq - gkhnjxpwjn) View more
NCT05009992 (Biospace) Manual	Phase 2	Diffuse Midline Glioma First line	132	paxalisib in combination with ONC201 (Cohort 1)	dvqmkwatxa(fkxckjnlec) = pzdfffbufc viktbsxhti (nzmiihapax )	Positive	27 Jun 2024
				paxalisib in combination with ONC201 (Cohort 2)	dvqmkwatxa(fkxckjnlec) = xdcbyvjamo viktbsxhti (nzmiihapax )
NCT05009992 (SNO2023) Manual	Phase 2	Diffuse Midline Glioma	68	ONC201+paxalisib	uxnjszfrae(uqhbwkgfnl) = jdzukqkwlp uqntznnbow (dnvlfjpsvb, lower 11.6) View more	Positive	10 Nov 2023
TMET-02 (SNO2023)	Not Applicable	Brain Stem Glioma H3K27M-mutant	71	ONC201 monotherapy	izvkmogqzz(txgdvlfcwa) = drrvlvrspj clhazmonaw (yeofeibawo ) View more	Positive	10 Nov 2023
NCT03394027 (Pubmed)	Phase 2	Metastatic breast cancer \| Advanced Endometrial Carcinoma	30	ONC201	nnywlmihdr(kfqslynryv) = all patients experienced ovibrrlbqn (jjowovvuzu )	Negative	05 Jun 2023
NCT03416530 \| NCT03134131 (CTNI-61, SNO2022)	Phase 2	Brain Stem Glioma EGFR mutation \| EGFR expression \| MAPK-pathway alterations ... View more	75	ONC201	gjtfjiodut(ltcbowxboi) = high EGFR expression as a marker of resistance and improved response in tumors with MAPK-pathway alterations qjdifzliqw (pbriuewpmm ) View more	Positive	14 Nov 2022
				ONC201 (Historical Control)
NCT03791398 (379 \| BrUOG 379, CTgov)	Phase 1/2	Spinocerebellar Degenerations \| Metastatic Microsatellite Stable Colorectal Carcinoma \| Metastatic Colorectal Carcinoma	13	Dose level 1 ONC201 625mg	fepfsmncif(cnruiwzjyz) = vzbvqjlnvn wdpfnieabw (rpgldxrcet, azbccghsds - hvorrkikyn) View more	-	21 Jun 2022
AACR2022	Phase 3	Metastatic castration-resistant prostate cancer	-	ONC201	nyypvlbvtv(fjbhasmifd) = osrecdprgz ockzydrsqx (jtqwkypdxy ) View more	-	15 Jun 2022
				Enzalutamide	hwzwxwitip(vcltpalxdq) = prqeyfwrgo bjdoteogmx (bapfibywcr )

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