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Safusidenib
Oligodendroglioma, Grade 2 Glioma (Astrocytoma Or Oligodendroglioma) With An Idh1 Mutation, Astrocytoma Idh Mutant Grade 2, Oligodendroglioma Idh-Mutant And 1P/19Q-Codeleted, Idh-Mutant Gliomas
Phase III
Not Yet Recruiting
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma
Jul 09, 2026
Safusidenib
Glioma, Oligodendroglioma, Idh1-Mutant Glioma, Astrocytoma Idh Mutant Grade 2, Grade 2 Idh1-Mutant Glioma, Grade 3 Idh1-Mutant Glioma, Oligodendroglioma Idh-1 Mutant And 1/P19q-Codeleted, Astrocytoma Idh Mutant Grade 3
Phase II
Not Yet Recruiting
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
Jul 09, 2026
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Crizotinib, Taletrectinib
Non Small Cell Lung Cancer
Phase III
Recruiting
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
Aug 12, 2024
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Nuv-1511
Pancreatic Cancer, Advanced Solid Tumor, Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Her2-Negative Breast Cancer, Platinum-Resistant Ovarian Cancer (Proc)
Phase I/II
Active Not Recruiting
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
Feb 12, 2024
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Multiple Administration Of Omeprazole Single Administration Of Ab-106
Pharmacokinetic Study
Phase I
Completed
Study the Effect of Omeprazole on AB-106 Pharmacokinetics
Oct 26, 2022
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Olaparib, Enzalutamide, Nuv-868
Prostate Neoplasm, Ovarian Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer, Advanced Solid Tumor, Triple Negative Breast Neoplasms, Triple Negative Breast Cancer, Cancer Of The Ovary, Triple-Negative Breast Cancer, Pancreas Cancer, Prostatic Cancer, Cancer Of Prostate, Cancer Of The Prostate, Castrate Resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration Resistant Prostatic Neoplasms, Breast Carcinoma, Cancer Of Pancreas, Cancer Of The Breast, Cancer Of Breast, Breast Tumor, Ovary Cancer, Cancer Of Ovary, Ovary Neoplasm, Cancer Of The Pancreas, Pancreas Neoplasm
Phase I
Terminated
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Jan 28, 2022
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Enzalutamide, Nuv-422
Prostate Neoplasm, Prostate Cancer, Prostatic Cancer, Cancer Of Prostate, Cancer Of The Prostate, Castrate Resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration Resistant Prostatic Neoplasms
Phase I/II
Withdrawn
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Dec 22, 2021
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Fulvestrant, Nuv-422
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Breast Carcinoma, Cancer Of The Breast, Cancer Of Breast, Malignant Tumor Of Breast, Breast Tumor
Phase I/II
Withdrawn
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
Dec 22, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Nuvation Bio (NUVB) have in its pipeline
NUVB is currently developing the following drugs: Safusidenib, Safusidenib, Taletrectinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.