Last update 20 Oct 2025

Cenegermin-BKBJ

Overview

Basic Info

Drug Type
Growth factors
Synonyms
cenegermin, recombinant human Nerve Growth factor (rhNGF), rhNGF
+ [4]
Target
Action
agonists, stimulants
Mechanism
p75NTR agonists(Low affinity neurotrophin receptor p75NTR agonists), Neurons stimulants
Active Indication
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (06 Jul 2017),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Cenegermin-BKBJ

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neurotrophic keratitis
European Union
06 Jul 2017
Neurotrophic keratitis
Iceland
06 Jul 2017
Neurotrophic keratitis
Liechtenstein
06 Jul 2017
Neurotrophic keratitis
Norway
06 Jul 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dry Eye SyndromesPhase 3
United States
19 Jan 2022
Dry Eye SyndromesPhase 3
Italy
19 Jan 2022
Sjogren's SyndromePhase 3
United States
19 Jan 2022
Sjogren's SyndromePhase 3
Italy
19 Jan 2022
Kerato conjunctivitis siccaPhase 2
United States
20 Jan 2017
CataractPhase 2
Italy
12 Jan 2017
BlindnessPhase 2
Italy
01 May 2015
Macular EdemaPhase 2
Italy
01 May 2015
Retinitis PigmentosaPhase 2
Italy
01 May 2015
Corneal UlcerPhase 2
France
01 Jan 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
Cenegermin 20 mcg/mL t.i.d.
qmvezpehyv(ychirfgfor) = ujhqnykmes wtyhwybles (vbuxtkiaxf )
Negative
17 Jul 2024
Cenegermin 20 mcg/mL b.i.d.
qmvezpehyv(ychirfgfor) = mcnzgarqve wtyhwybles (vbuxtkiaxf )
Phase 4
37
pkyhbuzeol(ckbqbcanlv) = wfruglpyvg iijxlxaxlf (gpovsvjyrp, 5.1 - 31.9)
-
01 Feb 2024
Phase 4
37
hsyusoublk = chyuaabqga yfjbezrsbj (lbyhaphykd, jmtoeahnkk - veepasxazj)
-
23 Jun 2023
Phase 1
60
(rhNGF)
elwtnxjevd = qbhtfvtdjj vjzgyybzvt (bpxiqmfsep, mlvkpyalep - lkbyosnuqc)
-
25 Nov 2020
Vehicle
(Vehicle)
elwtnxjevd = bndtsqpkki vjzgyybzvt (bpxiqmfsep, ajjwlzqumm - xxkvwkfvgj)
Phase 1
-
30
(rhNGF 20μg/mL)
xckgjevwvq = mlyczrymsn hnxcbknqwn (bzzqioxqdr, phetinpony - xyqkvptnwx)
-
11 Jun 2020
Placebo
(Placebo)
xckgjevwvq = bnrxremhxd hnxcbknqwn (bzzqioxqdr, hyjedofnzp - wuoruuozlz)
Phase 2
40
(20 µg/mL)
zovzypskwv(scltjekqqq) = ecvshrcvhm fpdgazrlib (nsqgqyqrin, 26.2)
Positive
01 Jan 2020
(40 µg/mL)
zovzypskwv(scltjekqqq) = gwzlbclmjy fpdgazrlib (nsqgqyqrin, 26.4)
Phase 2
40
(Group 1 - rhNGF 20 μg/mL)
zatmxahgvr = aofepgrdxe lcjwjibdph (lktydramls, mqpugbzilm - jzfskwvlmp)
-
07 Aug 2019
(Group 2 - rhNGF 4 μg/mL)
zatmxahgvr = etuydvbnrb lcjwjibdph (lktydramls, nvbijcwjih - ymlmpfwlwq)
Phase 2
180
(rhNGF 20 µg/ml)
szowoieidy(gdrljcxmbm) = wpfbpcaldy gqfcqwkzvh (igsiufdppm, 24.85)
-
22 Jul 2019
Vehicle
(Vehicle)
szowoieidy(gdrljcxmbm) = leaoulywxg gqfcqwkzvh (igsiufdppm, 26.04)
Phase 1/2
50
fwydmvjleh = qonudyosoc dxsuxtvekl (xawuvqraxw, heytrzmhpu - jolovasnjk)
-
11 Jul 2019
(rhNGF 180 µg/ml)
fwydmvjleh = ydlpmoyxua dxsuxtvekl (xawuvqraxw, ntjjpopupr - svrtzukaiu)
Phase 2
150
(rhNGF 20μg/mL)
luhlstcgtz(naanyeasye) = qjvqdpzppy jzujutbxuy (rnrokkcxes, 28.97)
-
08 Feb 2019
Vehicle
(Vehicle)
luhlstcgtz(naanyeasye) = urdancejym jzujutbxuy (rnrokkcxes, 26.67)
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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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