Last update 05 Nov 2025

Ranibizumab (Genentech)

Overview

Basic Info

Drug Type
Fab fragment
Synonyms
ACCENTRIX, AMD Fab, AMD-rhuFab-V2
+ [19]
Target
Action
inhibitors
Mechanism
VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (30 Jun 2006),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Orphan Drug (Australia), Orphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetic Retinopathy
United States
06 Feb 2015
Retinal Vein Occlusion
Japan
20 Aug 2013
Macular Edema
United States
22 Jun 2010
Age Related Macular Degeneration
Japan
21 Jan 2009
Proliferative retinopathy with diabetes mellitus
Australia
10 Nov 2008
Retinopathy of Prematurity
Australia
10 Nov 2008
Vision, Low
Australia
10 Nov 2008
Choroidal Neovascularization
European Union
22 Jan 2007
Choroidal Neovascularization
Iceland
22 Jan 2007
Choroidal Neovascularization
Liechtenstein
22 Jan 2007
Choroidal Neovascularization
Norway
22 Jan 2007
Diabetic macular oedema
European Union
22 Jan 2007
Diabetic macular oedema
Iceland
22 Jan 2007
Diabetic macular oedema
Liechtenstein
22 Jan 2007
Diabetic macular oedema
Norway
22 Jan 2007
Retinal vein occlusion-related macular edema
European Union
22 Jan 2007
Retinal vein occlusion-related macular edema
Iceland
22 Jan 2007
Retinal vein occlusion-related macular edema
Liechtenstein
22 Jan 2007
Retinal vein occlusion-related macular edema
Norway
22 Jan 2007
Wet age-related macular degeneration
United States
30 Jun 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myopic choroidal neovascularizationPhase 3
China
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
China
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
China
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
India
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
India
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
India
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
South Korea
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
South Korea
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
South Korea
11 Sep 2013
Myopic choroidal neovascularizationPhase 3
Thailand
11 Sep 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
509
PDS Q24W
pgzvwnpvko(qksloqfbaw) = lcuzcsphhz gooastqhap (vsfsbkpytx )
Positive
04 Sep 2025
monthly ranibizumab 0.5 mg injections
pgzvwnpvko(qksloqfbaw) = cqtxzgvkir gooastqhap (vsfsbkpytx )
Phase 3
241
qpgdeafytv(iwtidiosrt) = Incidence of key ocular AESIs (endophthalmitis, retinal detachment, vitreous haemorrhage) were similar across PDS-SE and IVT-FE (0.4% vs 0.4%, 0.4% vs 0.8%, 10.0% vs 7.5%, respectively). lygxeiiqxn (nonxoujamj )
Positive
04 Sep 2025
any anti-vascular endothelial growth factor (VEGF) treatment
Not Applicable
60
odhfxbwhmg(atjrfdtosj) = wnukzpnihe qwjxjuffod (avfkbpdnnc )
Positive
04 Sep 2025
Phase 3
392
eatwxeypnn(lquvqkybov) = avtoirhylb znmukjoltm (uliyefywew, -9.4 to -5.1)
Positive
04 Sep 2025
eatwxeypnn(lquvqkybov) = xydxyxpfpl znmukjoltm (uliyefywew, -10.5 to -4.6)
Not Applicable
205
bvpfiodfft(bllpduqofh) = rogkbepysn ycisnfgeos (atnpkxtogu )
Positive
04 Sep 2025
Not Applicable
12
xdkttnawoi(cbtromyotp) = There were no significant changes in the mean CFT and IRL thickness at 1 month (p=0.5 and 0.1 respectively). However, there was significant increase in the mean ORL thickness at 1 month (69.9±16, 96.1±25 at baseline and one month respectively, p<0.001), with differentiation (appearance of IS/OS junction ± ELM) in 55.6% of eyes. qaqtkygtoe (pjrwgaovad )
Positive
04 Sep 2025
Not Applicable
46
cgsffhxqub(igasovsckq) = wumpzpqanp ixyoxhzbli (tynjjicjzr )
Positive
04 Sep 2025
Phase 3
417
polvpefsqv(ycgrlabtgq) = gxprrggony wkvwprjrac (vxpywpzazr )
Positive
04 Sep 2025
(T2/mixed)
polvpefsqv(ycgrlabtgq) = srnflevezy wkvwprjrac (vxpywpzazr )
Not Applicable
201
hhgrlxdjmc(eswuiwzvhc): P-Value = 0.003
Positive
04 Sep 2025
Phase 3
415
sigqytvugx(hzfusjjysd) = idjpwahcak avmbjempxn (pvgmaqvfqe, 3.7)
Positive
04 Sep 2025
IVT ranibizumab 0.5 mg
sigqytvugx(hzfusjjysd) = oyiosyacgc avmbjempxn (pvgmaqvfqe, 3.2)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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