Aflibercept
Highest phase reached
Approved
Drug type
Protein
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Aflibercept
- eylea
- Eylea
- yesafili
- Yesafili
- zaltrap
- Zaltrap
- 0 5mg aflibercept
- 0.5mg aflibercept
- 8 mg aflibercept (BAY 86-5321) (High Dose)
- abp 938
- ABP 938
- ABP 938 8 mg
- ABP-938
- aflibercept
- Aflibercept
- AFLIBERCEPT
- Aflibercept (2.0 mg)
- Aflibercept (Eylea®) - US only
- Aflibercept (genetical recombination)
- AFLIBERCEPT (GENETICAL RECOMBINATION) [JAN]
- Aflibercept (US) 8 mg
- aflibercept (ziv-aflibercept)
- aflibercept [INN]
- AFLIBERCEPT [JAN]
- AFLIBERCEPT [MART.]
- AFLIBERCEPT [MI]
- AFLIBERCEPT [PURPLE BOOK CDER]
- AFLIBERCEPT [USAN]
- AFLIBERCEPT [VANDF]
- Aflibercept [WHO-DD]
- aflibercept + FOLFIRI
And 136 more, listed on the interactive page.
- CAS registry numbers
- 862111-32-8
- ChEMBL ID
- CHEMBL1742982
- FDA ingredient codes (UNII)
- 15C2VL427D
- L01XX44
- S01LA05
Sources for recorded values
- 1232150
- 1304475
- 2706479
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 18 Nov 2011
- Application number
- BLA125387
- Status
- Authorised
- Status date
- 21 Nov 2012
- Authorisation date
- 21 Nov 2012
- Approved indications
- Eylea 114.3 mg/ml solution for injection and Eylea 114.3 mg/ml solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to diabetic macular oedema (DME) visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO) Eylea 40 mg/mL solution for injection in pre-filled syringe Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV) Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease Eylea 40 mg/mL solution for injection in a vial Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)
- Product number
- EMEA/H/C/002392
- Authorisation holder
- Bayer AG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 12
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Choroidal Neovascularization
- Diabetes Complications
- Macular Edema
- Retinal Vein Occlusion
- Wet Macular Degeneration
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 8 Feb 2030
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- aflibercept
- Type
- Peptide
- Drug name stem
- -cept
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- VEGFA
- Gene symbol
- VEGFA
- Primary target
- Yes
- Mechanism
- Placenta growth factor inhibitor
- Action type
- Inhibitor
- Target
- Placenta growth factor
- Protein identifier
- P49763
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Protein identifier
- P15692
- Mechanism
- Placenta growth factor inhibitor
- Action type
- Inhibitor
- Target
- Placenta growth factor
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Adenocarcinoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000501
- Subject identifier
- D018263
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000641
- Subject identifier
- D013964
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- 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
- Macular Degeneration
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Astrocytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002499
- Subject identifier
- D001254
- Condition
- Oligodendroglioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002501
- Subject identifier
- D009837
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002617
- Subject identifier
- D008545
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Diabetic Retinopathy
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003770
- Subject identifier
- D003930
- Condition
- Brain Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003833
- Subject identifier
- D001932
- Condition
- Retinal Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003839
- Subject identifier
- D012164
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004142
- Subject identifier
- D015179
- Condition
- Myopia, Degenerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004207
- Subject identifier
- D047728
- Condition
- Carcinoid Tumor
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004243
- Subject identifier
- D002276
- Condition
- Wet Macular Degeneration
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004683
- Subject identifier
- D057135
- Condition
- Retinal Neovascularization
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005753
- Subject identifier
- D015861
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
And 28 more, listed on the interactive page.
- Condition identifier
- EFO_0000365
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002499
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002501
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002617
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003770
- Condition identifier
- EFO_0003833
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003839
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003893
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003966
- Condition identifier
- EFO_0004142
- Condition identifier
- EFO_0004207
- Condition identifier
- EFO_0004207
- Highest recorded phase
- 4
- Condition identifier
- EFO_0004243
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004683
- Condition identifier
- EFO_0005288
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005753
And 106 more, listed on the interactive page.
- Event
- age-related macular degeneration
- Reports
- 50
- Reporting signal score
- 158.957
- Event
- anterior chamber cell
- Reports
- 64
- Reporting signal score
- 243.017
- Event
- anterior chamber inflammation
- Reports
- 58
- Reporting signal score
- 221.419
- Event
- blindness
- Reports
- 556
- Reporting signal score
- 1,542.43
- Event
- blindness transient
- Reports
- 361
- Reporting signal score
- 1,379.52
- Event
- blindness unilateral
- Reports
- 257
- Reporting signal score
- 799.987
- Event
- cataract
- Reports
- 146
- Reporting signal score
- 181.431
- Event
- cataract operation
- Reports
- 87
- Reporting signal score
- 245.297
- Event
- choroidal neovascularisation
- Reports
- 30
- Reporting signal score
- 88.9736
- Event
- detachment of retinal pigment epithelium
- Reports
- 54
- Reporting signal score
- 176.373
- Event
- device use issue
- Reports
- 121
- Reporting signal score
- 350.68
- Event
- dry age-related macular degeneration
- Reports
- 29
- Reporting signal score
- 124.882
- Event
- endophthalmitis
- Reports
- 535
- Reporting signal score
- 2,141.24
- Event
- eye disorder
- Reports
- 78
- Reporting signal score
- 99.6933
- Event
- eye haemorrhage
- Reports
- 228
- Reporting signal score
- 684.966
- Event
- eye infection
- Reports
- 71
- Reporting signal score
- 142.401
- Event
- eye inflammation
- Reports
- 257
- Reporting signal score
- 892.29
- Event
- eye laser surgery
- Reports
- 29
- Reporting signal score
- 121.643
- Event
- eye operation
- Reports
- 43
- Reporting signal score
- 120.72
- Event
- eye pain
- Reports
- 233
- Reporting signal score
- 453.749
- Event
- foreign body sensation in eyes
- Reports
- 41
- Reporting signal score
- 101.882
- Event
- glaucoma
- Reports
- 66
- Reporting signal score
- 91.9272
- Event
- hypertension
- Reports
- 309
- Reporting signal score
- 163.023
- Event
- hypopyon
- Reports
- 54
- Reporting signal score
- 184.258
- Event
- intraocular pressure decreased
- Reports
- 26
- Reporting signal score
- 94.2228
And 29 more, listed on the interactive page.
- NCT00036946
- NCT00045266
- NCT00082823
- NCT00083213
- NCT00876044
- NCT00320775
- NCT00320788
- NCT00509795
- NCT00527423
- NCT00637377
- NCT01482910
- NCT02540954
- NCT04684394
- NCT05571267
- NCT00357760
- NCT00369590
- NCT00650923
- NCT00369655
- NCT00383370
- NCT00964795
- NCT01414153
- NCT01796964
- NCT01926977
- NCT01940887
- NCT02204683
And 138 more, listed on the interactive page.
- Dose
- 8 mg
- Route
- Intravitreal
- How often
- Every 4 weeks for the first three doses, then once every 8 to 16 weeks, +/- 1 week
- Discard unused portion
- Only administered by a qualified physician
- Use sterile technique
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Fusion Protein
- Type
- Protein
- Sequence
- SDTGRPFVEMYSEIPEIIHMTEGRELVIPCRVTSPNITVTLKKFPLDTLIPDGKRIIWDSRKGFIISNATYKEIGLLTCEATVNGHLYKTNYLTHRQTNTIIDVVLSPSHGIELSVGEKLVLNCTARTELNVGIDFNWEYPSSKHQHKKLVNRDLKTQSGSEMKKFLSTLTIDGVTRSDQGLYTCAASSGLMTKKNSTFVRVHEKDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- 0024-5840
- 0024-5841
- 55513-056
- 55513-065
- 61755-005
- 61755-050
- 61755-051
- 83257-035
- 85006-2908
Related records
Trials (468)
- 24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.
- 3 Month Outcome of Ziv-aflibercept for DME
- 4D-150 in Patients With Diabetic Macular Edema
- 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
- 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
- 5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer
- A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
- A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
- A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
- A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration
- A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
- A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
- A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
- A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
- A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
- A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
- A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
- A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
- A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
- A Long-term Follow up Study of EXG102-031 in Patients With wAMD (Everest LTFU)
Approved for (11)
- Cancer
- Colorectal adenocarcinoma
- Colorectal cancer
- Colorectal neoplasm
- Degenerative myopia
- Diabetic retinopathy
- Macular retinal edema
- Neoplasm
- Ocular vascular disorder
- Retinal vein occlusion
- Wet macular degeneration
In development for (41)
- Adult glioblastoma Phase 1
- Age-related macular degeneration Phase 3
- Anaplastic astrocytoma Phase 2
- Anaplastic oligodendroglioma Phase 2
- Autosomal recessive inherited pseudoxanthoma elasticum Phase 2
- Brain neoplasm Phase 2
- Breast cancer Phase 2
- Carcinoid tumor Phase 2
- Central serous chorioretinopathy Phase 2
- Choroidal neovascularization Phase 3
- Corneal neovascularization Phase 1
- Cutaneous melanoma Phase 3
- Endometrial carcinoma Phase 2
- Euthyroid Graves orbitopathy Phase 2
- Glaucoma Phase 3
- Gliosarcoma Phase 2
- Histoplasmosis Phase 1
- Iris melanoma Phase 2
- Leukemia Phase 2
- Lymphoma Phase 1
Other linked conditions (6)
- Diabetic macular edema
- Eye disorder
- Hemangioma of retina
- Myopia
- Proliferative diabetic retinopathy
- Retinal vasculitis