CC-486

Phase 2Small molecule

Bristol-Myers Squibb

CC-486 is one of 268 small molecule programs targeting Plasmacytoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

267

Competitors

Pipeline

Status by Indication[3][1]

Indication

PlasmacytomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

LymphomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Follicular LymphomaActive, not recruiting

PlasmacytomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 1

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Myelodysplastic SyndromesPhase 1/Phase 2

Active, not recruiting

Follicular LymphomaPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

CC-486

Bristol-Myers Squibb

Phase 2

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Oncaspar

SServier

Preclinical

15 5

Tafasitamab

Incyte

Preclinical

7 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 9

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

3 10

VP-16

FFundamenta Therapeutics, Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Plasmacytoma

NCT04174196

Q1 2029

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05287568

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia3 trials

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04887857·6 enrolled

An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT05413018·34 enrolled

CC-486 and Venetoclax for Acute Myeloid Leukemia

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT05287568·35 enrolled

Non-Small Cell Lung Cancer2 trials

Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02546986·100 enrolled

Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02250326·240 enrolled

Hematologic Malignancies1 trial

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02223052·89 enrolled

Plasmacytoma1 trial

A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04174196·21 enrolled

Myelodysplastic Syndromes1 trial

Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT01835587·31 enrolled

13 more indications

Colorectal Cancer1 trial

A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02512172·27 enrolled

Lymphoma1 trial

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT04639843

Relapsed/Refractory1 trial

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04447027·26 enrolled

Efficacy and Safety1 trial

Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02374099·97 enrolled

CLE1 trial

Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

Completed·KKirby Institute·Phase 2·NCT03493646·40 enrolled

ESS1 trial

Expanded Access for CC-486

Approved for marketing· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03723135

Oral1 trial

A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02494258·5 enrolled

Refractory Solid Tumors1 trial

A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01478685·169 enrolled

Nasopharyngeal Carcinoma1 trial

Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02269943·36 enrolled

Pilot Study1 trial

Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients

Active, not recruiting·UUniversity of Florence·Phase 2·NCT04806906·11 enrolled

Myeloid Malignancies1 trial

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

Ovarian Cancer1 trial

Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer

Terminated·TTranslational Research in Oncology·Phase 2·NCT02900560·34 enrolled

Follicular Lymphoma1 trial

A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma

Terminated·UUniversity of Chicago·Phase 1/2·NCT04722601·2 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for CC-486. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CC-486 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for CC-486. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Bristol-Myers Squibb

CC-486

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2029

Trials by Indication[1]

Acute Myeloid Leukemia3 trials

Non-Small Cell Lung Cancer2 trials

Hematologic Malignancies1 trial

Plasmacytoma1 trial

Myelodysplastic Syndromes1 trial

Colorectal Cancer1 trial

Lymphoma1 trial

Relapsed/Refractory1 trial

Efficacy and Safety1 trial

CLE1 trial

ESS1 trial

Oral1 trial

Refractory Solid Tumors1 trial

Nasopharyngeal Carcinoma1 trial

Pilot Study1 trial

Myeloid Malignancies1 trial

Ovarian Cancer1 trial

Follicular Lymphoma1 trial

References

Drug Info

Quick Facts

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