Diffuse Intrinsic Pontine Glioma

Oncology
11
Pipeline Programs
7
Companies
50
Clinical Trials
10 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
1
3
0
1
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
250%
Peptide
125%
Monoclonal Antibody
125%
+ 5 programs with unclassified modality

On Market (2)

Approved therapies currently available

U
EVEROLIMUSApproved
everolimus
Unknown Company
oral2025
Novartis
KISQALIApproved
ribociclib
Novartis
oral2017

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
1 program
1
1
KISQALI(ribociclib)Phase 1Small Molecule5 trials
Active Trials
NCT05038631Available
NCT07243002Recruiting3,000Est. May 2030
NCT07237256Not Yet Recruiting3,902Est. Dec 2037
+2 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
3 programs
1
1
1
EverolimusPhase 31 trial
ONC201Phase 21 trial
DordavipronePhase 11 trial
Active Trials
NCT03416530Terminated134Est. May 2023
NCT05009992Recruiting360Est. Jun 2029
NCT05476939Recruiting433Est. Sep 2031
Cook Medical
Cook MedicalIN - Bloomington
1 program
1
BevacizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01182350TerminatedEst. Jun 2016
SonALAsense
SonALAsenseCA - Oakland
1 program
1
SONALA-001Phase 21 trial
Active Trials
NCT05123534SuspendedEst. Oct 2024
Bristol Myers Squibb
1 program
1
K27M peptidePhase 1/2Peptide1 trial
Active Trials
NCT02960230Completed50Est. Dec 2023
Curis
CurisMA - Lexington
1 program
1
FimepinostatPhase 1Small Molecule1 trial
Active Trials
NCT03893487Active Not RecruitingEst. Aug 2027
Secura Bio
Secura BioNV - Las Vegas
1 program
1
MarizomibPhase 11 trial
Active Trials
NCT04341311Terminated4Est. Feb 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Novartisribociclib
Novartisribociclib
Jazz PharmaceuticalsEverolimus
Novartisribociclib
Novartisribociclib
Novartisribociclib
Novartisribociclib
Novartisribociclib
SonALAsenseSONALA-001
Novartisribociclib
Jazz PharmaceuticalsONC201
Novartisribociclib
Novartisribociclib
Novartisribociclib
Novartisribociclib

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 23,035 patients across 50 trials

NCT05452213Novartisribociclib

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

Start: Oct 2022Est. completion: Oct 20261,000 patients
Phase 4Recruiting
NCT07237256Novartisribociclib

Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib

Start: Dec 2025Est. completion: Dec 20373,902 patients
Phase 3Not Yet Recruiting
NCT05476939Jazz PharmaceuticalsEverolimus

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0

Start: Sep 2022Est. completion: Sep 2031433 patients
Phase 3Recruiting
NCT04055493Novartisribociclib

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Start: Jul 2019Est. completion: Jul 20271,684 patients
Phase 3Active Not Recruiting
NCT03701334Novartisribociclib

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Start: Dec 2018Est. completion: May 20305,101 patients
Phase 3Active Not Recruiting
NCT03462251Novartisribociclib

Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line

Start: May 2018Est. completion: Nov 202241 patients
Phase 3Completed
NCT03081234Novartisribociclib

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer

Start: Mar 2018Est. completion: Nov 20250
Phase 3Withdrawn
NCT02422615Novartisribociclib

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

Start: Jun 2015Est. completion: Jan 2023726 patients
Phase 3Completed
NCT05123534SonALAsenseSONALA-001

A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG

Start: Aug 2022Est. completion: Oct 2024
Phase 2Suspended
NCT05296746Novartisribociclib

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

Start: May 2022Est. completion: Dec 20311,100 patients
Phase 2Recruiting
NCT05009992Jazz PharmaceuticalsONC201

Combination Therapy for the Treatment of Diffuse Midline Gliomas

Start: Oct 2021Est. completion: Jun 2029360 patients
Phase 2Recruiting
NCT04417621Novartisribociclib

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Start: Oct 2020Est. completion: Feb 2027134 patients
Phase 2Active Not Recruiting
NCT03944434Novartisribociclib

FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer

Start: Dec 2018Est. completion: Nov 2025116 patients
Phase 2Active Not Recruiting
NCT03285412Novartisribociclib

CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

Start: Dec 2017Est. completion: Oct 2026120 patients
Phase 2Active Not Recruiting
NCT03078751Novartisribociclib

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

Start: Jun 2017Est. completion: Mar 202054 patients
Phase 2Completed
NCT02934568Novartisribociclib

Ribociclib (LEE011) Rollover Study for Continued Access

Start: Dec 2016Est. completion: Feb 202722 patients
Phase 2Active Not Recruiting
NCT02632045Novartisribociclib

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

Start: Mar 2016Est. completion: Jan 2022169 patients
Phase 2Completed
NCT02420691Novartisribociclib

Ribociclib in Treating Patients With Advanced Neuroendocrine Tumors of Foregut Origin

Start: Aug 2015Est. completion: Jun 201921 patients
Phase 2Completed
NCT01182350Cook MedicalBevacizumab

Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)

Start: Sep 2011Est. completion: Jun 2016
Phase 2Terminated
NCT07164976Novartisribociclib

Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

Start: Oct 2025Est. completion: Apr 203086 patients
Phase 1/2Not Yet Recruiting
NCT06726148Novartisribociclib

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Start: Apr 2025Est. completion: Sep 2028280 patients
Phase 1/2Recruiting
NCT03090165Novartisribociclib

Ribociclib and Bicalutamide in AR+ TNBC

Start: May 2018Est. completion: Oct 202637 patients
Phase 1/2Active Not Recruiting
NCT02960230Bristol Myers SquibbK27M peptide

H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas

Start: Nov 2016Est. completion: Dec 202350 patients
Phase 1/2Completed
NCT02607124Novartisribociclib

A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy

Start: Apr 2016Est. completion: Aug 201811 patients
Phase 1/2Terminated
NCT02657343Novartisribociclib

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Start: Mar 2016Est. completion: Jun 202225 patients
Phase 1/2Completed
NCT02555189Novartisribociclib

Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

Start: Dec 2015Est. completion: Sep 202346 patients
Phase 1/2Completed
NCT02494921Novartisribociclib

LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC

Start: Nov 2015Est. completion: Jul 202143 patients
Phase 1/2Completed
NCT05870579Novartisribociclib

[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer

Start: Nov 2023Est. completion: Jan 203248 patients
Phase 1Recruiting
NCT05429502Novartisribociclib

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Start: Dec 2022Est. completion: Feb 202512 patients
Phase 1Terminated
NCT04315233Novartisribociclib

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Start: May 2021Est. completion: Aug 202634 patients
Phase 1Recruiting
NCT04341311Secura BioMarizomib

Phase I Study of Marizomib + Panobinostat for Children With DIPG

Start: Aug 2020Est. completion: Feb 20244 patients
Phase 1Terminated
NCT04213404Novartisribociclib

Ribociclib and Spartalizumab in R/M HNSCC

Start: Mar 2020Est. completion: Jan 202513 patients
Phase 1Unknown
NCT03893487CurisFimepinostat

Fimepinostat in Treating Brain Tumors in Children and Young Adults

Start: Aug 2019Est. completion: Aug 2027
Phase 1Active Not Recruiting
NCT04000529Novartisribociclib

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Start: Jul 2019Est. completion: Jan 2024122 patients
Phase 1Terminated
NCT03434262Novartisribociclib

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Start: Mar 2018Est. completion: May 202468 patients
Phase 1Completed
NCT03333343Novartisribociclib

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

Start: Jan 2018Est. completion: Oct 2026105 patients
Phase 1Active Not Recruiting
NCT03416530Jazz PharmaceuticalsDordaviprone

ONC201 in Pediatric H3 K27M Gliomas

Start: Jan 2018Est. completion: May 2023134 patients
Phase 1Terminated
NCT03355794Novartisribociclib

A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

Start: Nov 2017Est. completion: Jul 202219 patients
Phase 1Completed
NCT02974725Novartisribociclib

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Start: Feb 2017Est. completion: Apr 2024241 patients
Phase 1Terminated
NCT02754011Novartisribociclib

Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 Negative

Start: Feb 2017Est. completion: Dec 202218 patients
Phase 1Completed
NCT02933736Novartisribociclib

Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients

Start: Oct 2016Est. completion: Mar 202748 patients
Phase 1Active Not Recruiting
NCT02780128Novartisribociclib

Next Generation Personalized Neuroblastoma Therapy

Start: Jul 2016Est. completion: Aug 202266 patients
Phase 1Terminated
NCT02703571Novartisribociclib

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Start: Jun 2016Est. completion: Sep 201995 patients
Phase 1Terminated
NCT02345824Novartisribociclib

Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma

Start: Mar 2016Est. completion: Jan 20203 patients
Phase 1Unknown
NCT02586675Novartisribociclib

TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

Start: Feb 2016Est. completion: Oct 20217 patients
Phase 1Completed
NCT02414724Novartisribociclib

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma

Start: May 2015Est. completion: Jun 201610 patients
Phase 1Terminated
NCT05038631Novartisribociclib

Managed Access Programs for LEE011, Ribociclib

N/AAvailable
NCT07243002Novartisribociclib

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

Start: Dec 2025Est. completion: May 20303,000 patients
N/ARecruiting
NCT06797531Novartisribociclib

RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Start: Aug 2025Est. completion: Nov 2028177 patients
N/ARecruiting
NCT06830720Novartisribociclib

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence

Start: Feb 2025Est. completion: Jun 20303,250 patients
N/ARecruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
10 actively recruiting trials targeting 23,035 patients
7 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)