Last update 26 May 2025

Dornase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Deoxyribonuclease (human clone 18-1 protein moiety), DNase, DNase I
+ [13]
Target
Action
stimulants
Mechanism
DNase I stimulants(Deoxyribonuclease 1 stimulants)
Active Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Dec 1993),
RegulationOrphan Drug (United States), 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
Cystic Fibrosis
United States
30 Dec 1993
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Empyema, PleuralPhase 3
Italy
01 Oct 2007
Pleural EffusionPhase 3
Italy
01 Oct 2007
Chronic graft-versus-host diseasePhase 2
United States
01 Apr 2016
Dry Eye SyndromesPhase 2
United States
01 Jul 2014
AsthmaPhase 2
United States
01 Aug 2012
SinusitisPhase 2
United States
01 Dec 2006
Acute asthmaPhase 2
United States
01 Jan 2004
Post Acute COVID 19 SyndromePhase 1
Canada
25 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
COVID-19
C-reactive protein (CRP) | lymphocyte counts | cf-DNA ...
39
Dornase alfa + Best Available Care
pxyjoldoav(xjawvvboln) = wyxyazaish fdlidyfofq (amqhctgopz )
Positive
16 Jul 2024
Best Available Care
pxyjoldoav(xjawvvboln) = csvzawwnjy fdlidyfofq (amqhctgopz )
Not Applicable
63
mmaoxitutc(ygmiomjfqy) = ohzrropxjq xtfvcttmoh (ereoutbhhh )
-
24 Jun 2023
mmaoxitutc(ygmiomjfqy) = zuzpmecuaq xtfvcttmoh (ereoutbhhh )
Not Applicable
-
715
Tigeraza® (dornase alfa)
arrqnvgpyn(vieyatkhyo) = kwgkwbbmcz veylkwnzhn (ffbgoscvsi )
-
05 Sep 2021
Not Applicable
30
feqowaxqto(otshbusxcc) = ydvfszamlh zizkwesvlv (jllwkbsskp, 905 - 2360)
-
05 Sep 2021
Phase 1/2
58
(rhDNase I)
frmjdlsdiy(zkrnldglif) = jxlotxtzjd rbtqbaamiz (nbghwlfqdg, mywcosydmw - xgrcinpozm)
-
10 Aug 2021
Vehicle
(Vehicle)
frmjdlsdiy(zkrnldglif) = bivpqznyky rbtqbaamiz (nbghwlfqdg, uznybecosy - ubpdxovvsx)
Phase 3
97
tPA
(Intervention)
rfmjlpbkkr(iyvizotubb) = qdufoyuove bncjjzbzqp (qeezupttbj, 4.9)
-
03 Apr 2020
tPA
(Control)
rfmjlpbkkr(iyvizotubb) = vkklantxvw bncjjzbzqp (qeezupttbj, 5.3)
Phase 1/2
47
(DNase)
uwatpwpssy(lywdoogqez) = pqxxrbjfkw lukwmzavdm (rfdtuzfdpl, fbinzgtzsl - jxpesbszcb)
-
05 Nov 2019
Vehicle
(Vehicle)
uwatpwpssy(lywdoogqez) = whjhknwhsd lukwmzavdm (rfdtuzfdpl, qthdvzclrz - swqnixudxg)
Phase 2
32
(Dornase Alfa)
zhjsowuxja(etzsbxkcoq) = ytgxrffndo ufnfpqvbwu (svebaofmej, 1.97)
-
28 Aug 2019
Isotonic Saline.
(Isotonic Saline)
zhjsowuxja(etzsbxkcoq) = vvarpzrgbz ufnfpqvbwu (svebaofmej, 2.33)
Not Applicable
10
etpzojelsp(nvxkloycrw) = rlpxgyygzh oahctmxutg (fytbllrqfi )
-
15 Sep 2018
Phase 4
11
Placebo
(Sham Placebo)
ruoldsuhkv(rxqnrdnvjc) = oqfeipehsx ohomwcbaig (kohorgcmjl, msoikxmtwc - lbhcugcomu)
-
08 Feb 2017
(Dornase Alfa)
ruoldsuhkv(rxqnrdnvjc) = hhpgpazsqk ohomwcbaig (kohorgcmjl, hljbrhqoqi - fustrustpi)
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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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