Abemaciclib
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Abemaciclib
- Molecular weight
- 506.61
- Structure (SMILES)
- CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
- verzenio
- Verzenio
- verzenios
- Verzenios
- abemaciclib
- Abemaciclib
- ABEMACICLIB
- ABEMACICLIB (LY2835219)
- Abemaciclib [INN]
- Abemaciclib [JAN]
- Abemaciclib [MI]
- Abemaciclib [ORANGE BOOK]
- Abemaciclib [USAN]
- Abemaciclib [WHO-DD]
- Abemaciclib 150 MG
- Abemaciclib 150 MG Oral Tablet
- Abemaciclib 200 MG
- Abemaciclib Capsules (Reference Formulation)
- abemaciclib inn
- abemaciclib jan
- abemaciclib ly2835219
- abemaciclib mi
- abemaciclib orange book
- Abemaciclib Tablet (Test Formulation)
- abemaciclib usan
- abemaciclib who dd
- Abemaciclib,
- cdk4 6 dual inhibitor
- CDK4/6 DUAL INHIBITOR
And 19 more, listed on the interactive page.
- ATC classification codes
- L01EF03
Sources for recorded values
- CAS registry numbers
- 1231929-97-7
- ChEMBL ID
- CHEMBL3301610
- InChIKey
- UZWDCWONPYILKI-UHFFFAOYSA-N
- PubChem compound IDs
- 46220502
- RxNorm IDs (RxCUI)
- 1946825
- FDA ingredient codes (UNII)
- 60UAB198HK
- Applicant
- ELI LILLY AND CO
- Approval date
- 28 Sept 2017
- Application number
- NDA208716
- Status
- Authorised
- Status date
- 26 Sept 2018
- Authorisation date
- 26 Sept 2018
- Approved indications
- Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
- Product number
- EMEA/H/C/004302
- Authorisation holder
- Eli Lilly Nederland B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Breast Neoplasms
European medicines record
- Patents
- 1
- Designations
- 5
- Earliest recorded loss of exclusivity
- 28 Sept 2031
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- abemaciclib
- Type
- Synthetic organic
- Drug name stem
- -ciclib
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- cyclin dependent kinase 4
- Gene symbol
- CDK4
- Protein identifier
- P11802
- Median affinity
- 8.7
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- cyclin dependent kinase 6
- Gene symbol
- CDK6
- Protein identifier
- Q00534
- Median affinity
- 8
- Affinity units
- pIC50
- Mechanism
- Cyclin-dependent kinase 4 inhibitor
- Action type
- Inhibitor
- Target
- Cyclin-dependent kinase 4
- Protein identifier
- P11802
- Mechanism
- Cyclin-dependent kinase 6 inhibitor
- Action type
- Inhibitor
- Target
- Cyclin-dependent kinase 6
- Protein identifier
- Q00534
- Mechanism
- Cyclin-dependent kinase 4 inhibitor
- Action type
- Inhibitor
- Target
- Cyclin-dependent kinase 4
- Mechanism
- Cyclin-dependent kinase 6 inhibitor
- Action type
- Inhibitor
- Target
- Cyclin-dependent kinase 6
- Action type
- Inhibitor
- Gene symbol
- CDK4
- Protein identifier
- P11802
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- CDK6
- Protein identifier
- Q00534
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Neuroblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Oligodendroglioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000632
- Subject identifier
- D009837
- Condition
- Osteosarcoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Multiple Myeloma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Rhabdomyosarcoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002918
- Subject identifier
- D012208
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Liposarcoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003085
- Subject identifier
- D008080
- Condition
- Cystadenocarcinoma, Serous
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003825
- Subject identifier
- D018284
- Condition
- Brain Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003833
- Subject identifier
- D001932
And 28 more, listed on the interactive page.
- Condition identifier
- EFO_0000174
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000305
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000558
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000621
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000632
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000637
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002918
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003085
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003825
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003833
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0004284
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004920
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005701
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009708
- Highest recorded phase
- 1
- Condition identifier
- EFO_0020983
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000026
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000294
- Highest recorded phase
- 2
And 86 more, listed on the interactive page.
- Event
- decreased appetite
- Reports
- 92
- Reporting signal score
- 48.6057
- Event
- dehydration
- Reports
- 98
- Reporting signal score
- 70.9643
- Event
- diarrhoea
- Reports
- 642
- Reporting signal score
- 764.553
- Event
- disease progression
- Reports
- 134
- Reporting signal score
- 162.495
- Event
- drug hypersensitivity
- Reports
- 2
- Reporting signal score
- 36.0898
- Event
- hospice care
- Reports
- 18
- Reporting signal score
- 34.0806
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 30.2984
- Event
- interstitial lung disease
- Reports
- 57
- Reporting signal score
- 54.5176
- Event
- malignant neoplasm progression
- Reports
- 105
- Reporting signal score
- 139.669
- Event
- metastases to bone
- Reports
- 30
- Reporting signal score
- 48.1799
- Event
- metastases to liver
- Reports
- 30
- Reporting signal score
- 48.6897
- Event
- metastases to lung
- Reports
- 21
- Reporting signal score
- 34.9877
- Event
- pik3ca-activated mutation
- Reports
- 11
- Reporting signal score
- 44.9632
- Event
- pneumonitis
- Reports
- 34
- Reporting signal score
- 36.3585
- Event
- therapy change
- Reports
- 35
- Reporting signal score
- 82.4682
- Event
- therapy interrupted
- Reports
- 57
- Reporting signal score
- 106.378
- Event
- tumour marker increased
- Reports
- 18
- Reporting signal score
- 42.2015
- Event
- vomiting
- Reports
- 147
- Reporting signal score
- 30.0381
- Event
- white blood cell count decreased
- Reports
- 75
- Reporting signal score
- 44.5355
- NCT01042379
- NCT01655225
- NCT02102490
- NCT02246621
- NCT02308020
- NCT02441946
- NCT02675231
- NCT02763566
- NCT02791334
- NCT02831530
- NCT03130439
- NCT03155997
- NCT03284957
- NCT03424005
- NCT03703466
- NCT03846583
- NCT03939897
- NCT03988114
- NCT04031885
- NCT04088032
- NCT04227327
- NCT04293393
- NCT04316169
- NCT04352777
- NCT04432454
And 105 more, listed on the interactive page.
- Dose
- 150 mg
- Route
- Oral
- How often
- Twice daily
- Hydrogen bond acceptors
- 8
- Hydrogen bond donors
- 1
- Polar surface area
- 75
- Calculated partition coefficient (ALogP)
- 4.94
- Calculated partition coefficient (XLogP)
- 3.8
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 7
- Heavy atoms
- 37
- Molecular formula
- C27H32F2N8
- Monoisotopic mass
- 506.27179938
- Natural product
- No
- 0002-4483
- 0002-4815
- 0002-5337
- 0002-6216
- Recorded assays
- 7,140
- Active assays
- 568
- Confirmatory
- Other
- Screening
These details could not be displayed.
Related records
Trials (231)
- (CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
- A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.
- A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy
- A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
- A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
- 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
- A Phase 1 Study of LY2835219 In Participants With Advanced Cancer
- A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
- A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
- A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
- A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer
- A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
- A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
- A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
- A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
- A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer
- A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
- A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Approved for (6)
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Cancer
- HER2 positive breast carcinoma
- Neoplasm
In development for (47)
- Angiosarcoma Phase 2
- Biliary tract cancer Phase 2
- Brain neoplasm Phase 2
- Clear cell renal carcinoma Phase 1
- Colorectal cancer Phase 1
- Cutaneous melanoma Phase 2
- Dedifferentiated liposarcoma Phase 3
- Diffuse intrinsic pontine glioma Phase 1
- Endometrial cancer Phase 2
- Ewing sarcoma Phase 1
- Female reproductive organ cancer Phase 2
- Glioblastoma Phase 2
- Head and neck squamous cell carcinoma Phase 2
- Hepatocellular carcinoma Phase 2
- Intracranial meningioma Phase 2
- Kaposi's sarcoma Phase 1
- Lung cancer Phase 2
- Lymphoma Phase 1
- Male breast carcinoma Phase 2
- Malignant glioma Early phase 1
Other linked conditions (1)
- Childhood medulloblastoma