Ranibizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2006
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Ranibizumab
- byooviz
- Byooviz
- lucentis
- Lucentis
- ranivisio
- Ranivisio
- rimmyrah
- Rimmyrah
- ximluci
- Ximluci
- 0 3 mg ranibizumab
- 0.3 mg ranibizumab
- 0.5mg intraocular Ranibizumab (Lucentis)
- 0.5mg ranibizumab
- 0.5mg Ranibizumab
- bcd 300
- BCD-300
- byooviz
- Byooviz
- cimerli
- Cimerli
- fab 12 variant y0317
- FAB-12 VARIANT Y0317
- fyb 201
- FYB-201
- fyb201
- FYB201
- immunoglobulin g1 anti human vascular endothelial growth factor fab fragment human mouse monoclonal rhufab v2 1 chain disulfide with human mouse monoclonal rhufab v2 light chain
- immunoglobulin G1, anti-(human vascular endothelial growth factor) Fab fragment (human-mouse monoclonal rhuFAB V2 1-chain), disulfide with human-mouse monoclonal rhuFAB V2 light chain
- intravitreal injection Lucentis (ranibizumab)
- lucentis
- Lucentis
- LUCENTIS (Ranibizumab Injection)
- Lucentis (ranibizumab)
- Lucentis (Ranibizumab)
And 103 more, listed on the interactive page.
- ATC classification codes
- S01LA04
Sources for recorded values
- CAS registry numbers
- 347396-82-1
- ChEMBL ID
- CHEMBL1201825
- FDA ingredient codes (UNII)
- ZL1R02VT79
- 595060
- 2612673
- Applicant
- GENENTECH
- Approval date
- 30 Jun 2006
- Application number
- BLA125156
- Status
- Authorised
- Status date
- 22 Jan 2007
- Authorisation date
- 22 Jan 2007
- Approved indications
- Lucentis is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to choroidal neovascularisation (CNV) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
- Product number
- EMEA/H/C/000715
- Authorisation holder
- Novartis Europharm Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 8
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Choroidal Neovascularization
- Diabetes Complications
- Macular Edema
- Myopia, Degenerative
- Wet Macular Degeneration
European medicines record
- Patents
- 0
- Designations
- 3
- Earliest recorded loss of exclusivity
- 3 Oct 2023
- 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
- Boxed warning
- Yes
- Pharmacology name
- ranibizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- VEGFA
- Gene symbol
- VEGFA
- Median affinity
- 9.82
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Protein identifier
- P15692
Open Targets mechanisms
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Pterygium
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000678
- Subject identifier
- D011625
- Condition
- Macular Degeneration
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Diabetic Retinopathy
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003770
- Subject identifier
- D003930
- Condition
- Retinal Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003839
- Subject identifier
- D012164
- Condition
- Glaucoma, Open-Angle
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004190
- Subject identifier
- D005902
- Condition
- Myopia, Degenerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004207
- Subject identifier
- D047728
- Condition
- Choroidal Neovascularization
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004683
- Subject identifier
- D020256
- 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
- Retinal Detachment
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005773
- Subject identifier
- D012163
- Condition
- Histoplasmosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007310
- Subject identifier
- D006660
- Condition
- Macular Degeneration
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009606
- Subject identifier
- D008268
- Condition
- Central Serous Chorioretinopathy
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009784
- Subject identifier
- D056833
- Condition
- Diabetes Complications
- Highest recorded phase
- 4
- Condition identifier
- EFO:0010977
- Subject identifier
- D048909
- Condition
- Uveal Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000616
- Subject identifier
- D000098943
- Condition
- Angioid Streaks
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000805
- Subject identifier
- D000793
- Condition
- Optic Neuropathy, Ischemic
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000809
- Subject identifier
- D018917
- Condition
- Corneal Neovascularization
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000880
- Subject identifier
- D016510
- Condition
- Glaucoma, Neovascular
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001060
- Subject identifier
- D015355
- Condition
- Retinal Vein Occlusion
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001157
- Subject identifier
- D012170
- Condition
- Retinopathy of Prematurity
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001158
- Subject identifier
- D012178
- Condition
- Myopia
- Highest recorded phase
- 1
- Condition identifier
- HP:0000545
- Subject identifier
- D009216
- Condition
- Myopia, Degenerative
- Highest recorded phase
- 4
- Condition identifier
- HP:0000545
- Subject identifier
- D047728
- Condition
- Retinal Hemorrhage
- Highest recorded phase
- 2
- Condition identifier
- HP:0000573
- Subject identifier
- D012166
And 10 more, listed on the interactive page.
- Condition identifier
- EFO_0000400
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000678
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003770
- Condition identifier
- EFO_0003839
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003895
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004190
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004207
- Condition identifier
- EFO_0004207
- Highest recorded phase
- 4
- Condition identifier
- EFO_0004683
- Condition identifier
- EFO_0005753
- Condition identifier
- EFO_0005773
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007310
- Condition identifier
- EFO_0008626
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009321
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009322
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009606
- Condition identifier
- EFO_0009760
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009784
- Highest recorded phase
- 1
- Condition identifier
- EFO_0010133
- Highest recorded phase
- 2
- Condition identifier
- EFO_0010977
- Highest recorded phase
- 4
- Condition identifier
- EFO_1000805
- Condition identifier
- EFO_1000809
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000880
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001060
- Highest recorded phase
- 3
And 59 more, listed on the interactive page.
- Event
- age-related macular degeneration
- Reports
- 282
- Reporting signal score
- 1,288.56
- Event
- anterior chamber cell
- Reports
- 45
- Reporting signal score
- 140.066
- Event
- anterior chamber inflammation
- Reports
- 42
- Reporting signal score
- 132.807
- Event
- blindness
- Reports
- 337
- Reporting signal score
- 655.329
- Event
- blindness unilateral
- Reports
- 88
- Reporting signal score
- 153.251
- Event
- cataract
- Reports
- 244
- Reporting signal score
- 341.678
- Event
- cataract nuclear
- Reports
- 65
- Reporting signal score
- 245.099
- Event
- cerebral infarction
- Reports
- 222
- Reporting signal score
- 331.788
- Event
- cerebrovascular accident
- Reports
- 675
- Reporting signal score
- 805.817
- Event
- choroidal neovascularisation
- Reports
- 187
- Reporting signal score
- 832.037
- Event
- cystoid macular oedema
- Reports
- 137
- Reporting signal score
- 460.834
- Event
- detachment of retinal pigment epithelium
- Reports
- 257
- Reporting signal score
- 1,153.08
- Event
- diabetic retinal oedema
- Reports
- 158
- Reporting signal score
- 749.695
- Event
- diabetic retinopathy
- Reports
- 67
- Reporting signal score
- 179.316
- Event
- diarrhoea
- Reports
- 34
- Reporting signal score
- 246.485
- Event
- disease progression
- Reports
- 288
- Reporting signal score
- 205.306
- Event
- disease recurrence
- Reports
- 146
- Reporting signal score
- 178.747
- Event
- dry age-related macular degeneration
- Reports
- 32
- Reporting signal score
- 130.15
- Event
- endophthalmitis
- Reports
- 553
- Reporting signal score
- 2,040.21
- Event
- eye discharge
- Reports
- 93
- Reporting signal score
- 207.291
- Event
- eye disorder
- Reports
- 99
- Reporting signal score
- 117.783
- Event
- eye haemorrhage
- Reports
- 269
- Reporting signal score
- 761.855
- Event
- eye inflammation
- Reports
- 114
- Reporting signal score
- 266.051
- Event
- eye irritation
- Reports
- 123
- Reporting signal score
- 150.915
- Event
- eye pain
- Reports
- 339
- Reporting signal score
- 672.073
And 56 more, listed on the interactive page.
- NCT00056823
- NCT00251459
- NCT00275821
- NCT00288561
- NCT00331864
- NCT00344227
- NCT00373659
- NCT00390208
- NCT00413829
- NCT00429962
- NCT00457678
- NCT00470678
- NCT00500344
- NCT00511706
- NCT00517010
- NCT00557791
- NCT00559715
- NCT00574093
- NCT00593450
- NCT00599222
- NCT00710229
- NCT00713518
- NCT00726466
- NCT00764738
- NCT00766337
And 199 more, listed on the interactive page.
- Dose
- 0.5 mg
- Route
- Intravitreal
- How often
- Once a month (approximately 28 days)
- Administered by intravitreal injection
- Retreat if needed
- Treat patients monthly
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGYDFTHYGMNWVRQAPGKGLEWVGWINTYTGEPTYAADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPYYYGTSHWYFDVWGQGTLVTVSSASTKGPSVFPLAPSGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPK
- Component
- Sequence
- Type
- Protein
- Sequence
- DIQLTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGE
- 50242-078
- 50242-080
- 50242-082
- 61314-624
- 61314-625
- 64406-019
- 70114-440
- 70114-441
- 82667-018
- 70710-2172
- 70710-2173
Related records
Trials (501)
- 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
- 24 Week Study to Compare Systemic VEGF-levels of Ranibizumab and Aflibercept in DME.
- 25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial
- 25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China
- 601 Versus Ranibizumab in Patients With Pathological Myopic Choroidal Neovascularization (pmCNV)
- A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
- A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
- 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 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema
- A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
- A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
- A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
- A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
- A Pharmacokinetic Study: Ranibizumab, Aflibercept and the Effect of Vitrectomy.
- A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema
- A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
- A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Approved for (8)
- Choroidal neovascularization
- Cystoid macular edema
- Degenerative myopia
- Diabetic retinopathy
- Macular retinal edema
- Myopia
- Ocular vascular disorder
- Wet macular degeneration
In development for (26)
- Age-related macular degeneration Phase 3
- Angioid streaks Phase 1
- Anterior ischemic optic neuropathy Phase 1
- Blindness (disorder) Phase 3
- Central serous chorioretinopathy Phase 1
- Conjunctival tumor Phase 1
- Corneal neovascularization Phase 1
- Diabetes mellitus Phase 2
- Diabetic macular edema Phase 3
- Familial multiple nevi flammei Phase 1
- Glaucoma Phase 3
- Histoplasmosis Phase 2
- Macular degeneration Phase 3
- Malignant choroid melanoma Phase 3
- Neovascular glaucoma Phase 3
- Open-angle glaucoma Phase 1
- Proliferative diabetic retinopathy Phase 3
- Pterygium Phase 2
- Retinal detachment Phase 2
- Retinal disorder Phase 2
Other linked conditions (2)
- Coats disease
- Hereditary hemorrhagic telangiectasia
Targets (1)
- VEGFA Vascular endothelial growth factor A inhibitor