Lenvatinib
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Lenvatinib
- Molecular weight
- 426.86
- Structure (SMILES)
- COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O
- kisplyx
- Kisplyx
- e 7080
- E-7080
- e7080
- E7080
- er 203492 00
- ER-203492-00
- lenvatinib
- Lenvatinib
- lenvatinib [INN]
- LENVATINIB [MI]
- LENVATINIB [USAN]
- Lenvatinib [WHO-DD]
- lenvatinib inn
- lenvatinib mi
- lenvatinib usan
- lenvatinib who dd
- CAS registry numbers
- 417716-92-8
- ChEMBL ID
- CHEMBL1289601
- InChIKey
- WOSKHXYHFSIKNG-UHFFFAOYSA-N
- PubChem compound IDs
- 9823820
- RxNorm IDs (RxCUI)
- 1603296
- FDA ingredient codes (UNII)
- EE083865G2
- L01EX08
- L01XE
- L01XE29
Sources for recorded values
- Applicant
- EISAI INC
- Approval date
- 13 Feb 2015
- Application number
- NDA206947
- Status
- Authorised
- Status date
- 28 May 2015
- Authorisation date
- 28 May 2015
- Approved indications
- Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.
- Product number
- EMEA/H/C/003727
- Authorisation holder
- Eisai GmbH
- 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
- Yes
- Exceptional circumstances
- No
Therapeutic areas
- Thyroid Neoplasms
European medicines record
- Patents
- 20
- Designations
- 2
- Earliest recorded loss of exclusivity
- 15 Nov 2038
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- lenvatinib
- Type
- Synthetic organic
- Drug name stem
- -tinib
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- fms related receptor tyrosine kinase 4
- Gene symbol
- FLT4
- Protein identifier
- P35916
- Median affinity
- 8.28
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- kinase insert domain receptor
- Gene symbol
- KDR
- Protein identifier
- P35968
- Median affinity
- 8.4
- Affinity units
- pIC50
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Vascular endothelial growth factor receptor inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor receptor
- Action type
- Inhibitor
- Gene symbol
- EGFR
- Protein identifier
- P00533
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- RET
- Protein identifier
- P07949
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- PDGFRB
- Protein identifier
- P09619
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- KIT
- Protein identifier
- P10721
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- FGFR1
- Protein identifier
- P11362
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- PDGFRA
- Protein identifier
- P16234
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- FLT1
- Protein identifier
- P17948
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- FLT4
- Protein identifier
- P35916
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- KDR
- Protein identifier
- P35968
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000178
- Subject identifier
- D013274
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Carcinoma, Adenoid Cystic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000231
- Subject identifier
- D003528
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Adenocarcinoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000501
- Subject identifier
- D018263
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- 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
- Osteosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000641
- Subject identifier
- D013964
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000770
- Subject identifier
- D008654
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001061
- Subject identifier
- D002583
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Liver Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002890
- Subject identifier
- D002292
And 37 more, listed on the interactive page.
- Condition identifier
- EFO_0000178
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000231
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000349
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000558
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000571
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002892
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003841
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0003891
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004230
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005221
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005708
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009870
- Highest recorded phase
- 2
And 122 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 89
- Reporting signal score
- 160.221
- Event
- ammonia increased
- Reports
- 48
- Reporting signal score
- 97.7371
- Event
- ascites
- Reports
- 103
- Reporting signal score
- 119.529
- Event
- blood pressure increased
- Reports
- 241
- Reporting signal score
- 207.146
- Event
- blood thyroid stimulating hormone increased
- Reports
- 44
- Reporting signal score
- 74.303
- Event
- cholangitis
- Reports
- 45
- Reporting signal score
- 76.51
- Event
- cholecystitis
- Reports
- 98
- Reporting signal score
- 194.835
- Event
- condition aggravated
- Reports
- 6
- Reporting signal score
- 87.9922
- Event
- decreased appetite
- Reports
- 718
- Reporting signal score
- 1,043.9
- Event
- dehydration
- Reports
- 187
- Reporting signal score
- 90.14
- Event
- diarrhoea
- Reports
- 811
- Reporting signal score
- 438.074
- Event
- drug hypersensitivity
- Reports
- 6
- Reporting signal score
- 92.973
- Event
- dysphonia
- Reports
- 134
- Reporting signal score
- 147.082
- Event
- fatigue
- Reports
- 577
- Reporting signal score
- 153.154
- Event
- hepatic encephalopathy
- Reports
- 269
- Reporting signal score
- 818.321
- Event
- hepatic function abnormal
- Reports
- 98
- Reporting signal score
- 79.0612
- Event
- hypertension
- Reports
- 743
- Reporting signal score
- 971.411
- Event
- hypothyroidism
- Reports
- 225
- Reporting signal score
- 438.805
- Event
- interstitial lung disease
- Reports
- 149
- Reporting signal score
- 141.402
- Event
- liver carcinoma ruptured
- Reports
- 20
- Reporting signal score
- 86.6755
- Event
- malignant neoplasm progression
- Reports
- 153
- Reporting signal score
- 125.062
- Event
- oral pain
- Reports
- 71
- Reporting signal score
- 87.9735
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 293
- Reporting signal score
- 633.941
- Event
- platelet count decreased
- Reports
- 204
- Reporting signal score
- 127.814
- Event
- proteinuria
- Reports
- 313
- Reporting signal score
- 749.753
And 3 more, listed on the interactive page.
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- NCT03744247
- NCT03746249
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- NCT03775707
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And 266 more, listed on the interactive page.
- Dose
- 24 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with or without food
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 3
- Polar surface area
- 115.57
- Calculated partition coefficient (ALogP)
- 4.07
- Calculated partition coefficient (XLogP)
- 2.8
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 6
- Heavy atoms
- 30
- Molecular formula
- C21H19ClN4O4
- Monoisotopic mass
- 426.1094828
- Natural product
- Yes
- 62856-704
- 62856-708
- 62856-710
- 62856-712
- 62856-714
- 62856-718
- 62856-720
- 62856-724
- Recorded assays
- 1,011
- Active assays
- 206
- Confirmatory
- Other
- Screening
- Antineoplastic Agents
- Protein Kinase Inhibitors
These details could not be displayed.
Related records
Trials (518)
- A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
- A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma
- A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
- A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma
- A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer
- A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
- A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
- A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers
- A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
- A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
- A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma
- A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours
- A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
- A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.
- A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
- A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
- A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma
- A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma
- A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma
Approved for (2)
- Cancer
- Neoplasm
In development for (60)
- Adenocarcinoma Phase 2
- Adenoid cystic carcinoma Phase 2
- Adrenal cortex carcinoma Phase 2
- Biliary tract cancer Phase 2
- Biliary tract neoplasm Phase 2
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Central nervous system neoplasm Phase 1
- Cervical cancer Phase 2
- Cervical carcinoma Phase 2
- Cholangiocarcinoma Phase 3
- Clear cell renal carcinoma Phase 3
- Colorectal neoplasm Phase 3
- Cutaneous neuroendocrine carcinoma Phase 2
- Endometrial cancer Phase 3
- Endometrial carcinoma Phase 3
- Esophageal cancer Phase 3
- Esophageal squamous cell carcinoma Phase 3
- Gastric adenocarcinoma Phase 2
- Gastric cancer Phase 2
Other linked conditions (3)
- Differentiated thyroid carcinoma
- Gastrointestinal stromal tumor
- Thyroid tumor