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dornase alfa

Trade name: pulmozyme

Recombinant proteinapprovedOrphan Drug FDA

Approved

Dec 30, 1993

Dornase alfa, sold under the brand name Pulmozyme, is used for the treatment of cystic fibrosis. It is a recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. Dornase alfa hydrolyzes the DNA present in sputum/mucus and reduces viscosity in the lungs, promoting improved clearance of secretions. It is produced in Chinese hamster ovary cells. — Wikipedia

Clinical trial activity

49 trials · 62 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
25
Phase 3
12
Phase 4
9

Earliest trial started Aug 1, 2003 (NCT00204685)

Timeline

1990s

  1. Jan 16, 1991

    Orphan Drug Designation

  2. Dec 30, 1993

    Genentech — Earliest FDA Approval

  3. Dec 30, 1993

    Genentech — Marketing Organization

  4. Dec 30, 1993

    Genentech — NDA Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 30, 1993

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • deanase
  • deoxyribonuclease
  • deoxyribonuclease
  • deoxyribonuclease (human clone 18-1 protein moiety)
  • desoxyribonuclease
  • desoxyribonuclease
  • desoxyribonuclease
  • dornase
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa
  • dornase alfa (desoxyribonuclease)
  • dornase alfa (genetical recombination)
  • dornase alfa, recombinant
  • dornase alpha
  • dornase alpha
  • human dnase-1
  • pulmozyme
  • pulmozyme
  • pulmozyme
  • pulmozyme
  • pulmozyme
  • recombinant deoxyribonuclease
  • recombinant deoxyribonuclease (dnase)
  • recombinant human deoxyribonuclease i
  • recombinant human dnase
  • rhdnase

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07121322Phase 2Jul 30, 2025National Cancer Institute (NCI), National Cancer Institute, Slovakia
NCT06723717Phase 2Feb 28, 2025Adolphe Rothschild Ophtalmologic Foundation, Hôpital Fondation Adolphe de Rothschild
NCT05880524Phase 2Dec 31, 2023Ludwig Maximilians University, University of Erlangen-Nuremberg, University of Regensburg
NCT05903417N/AJul 10, 2023National University of Malaysia
NCT05203224Phase 2Feb 18, 2022University of Melbourne
NCT05139901Phase 4Dec 31, 2021University of Ljubljana
NCT04785066Phase 2Oct 31, 2021Adolphe Rothschild Ophtalmologic Foundation
NCT05279391N/AOct 25, 2020Democritus University of Thrace
NCT06350474N/AAug 25, 2020Cystic Fibrosis Foundation, Dartmouth University, University of Washington
NCT04378153N/AJul 15, 2020Cystic Fibrosis Foundation, Dartmouth University, Icahn School of Medicine at Mount Sinai, University of Washington
NCT04459325Phase 3Jun 1, 2020AO GENERIUM
NCT04402970Phase 3May 30, 2020University of Missouri
NCT04402944Phase 2May 25, 2020Harvard University
NCT04432987Phase 2May 25, 2020Acibadem University, The Scientific and Technological Research Council of Turkey
NCT04359654Phase 2May 1, 2020University of London
NCT04355364Phase 3Apr 15, 2020Adolphe Rothschild Ophtalmologic Foundation, University of Lorraine, University of Strasbourg
NCT04915586N/ADec 30, 2019National University of Malaysia
NCT03368092Phase 3Nov 1, 2018University of Strasbourg
NCT03584113N/ASep 30, 2018Queen's University, Belfast
NCT03586076Phase 1Jan 26, 2018Eden Biologics, Pharmaceutical Research Associates, Inc. (PRA)
Showing 20 of 49 trials
Page 1 / 3

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenentechFor profit12342004
Adolphe Rothschild Ophtalmologic FoundationAcademic/Hospital3322020
AO GENERIUMFor profit2212017
Cystic Fibrosis FoundationAcademic/Hospital2012020
Dartmouth UniversityAcademic/Hospital2012020
Friedrich Schiller UniversityAcademic/Hospital2212005
National University of MalaysiaAcademic/Hospital2212019
University of Illinois at ChicagoAcademic/Hospital2212014
University of LondonAcademic/Hospital2112005
University of StrasbourgAcademic/Hospital2112018
University of TorontoAcademic/Hospital2222008
University of WashingtonAcademic/Hospital2112020
Acibadem UniversityAcademic/Hospital1112020
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012012
Democritus University of ThraceAcademic/Hospital1112020
Duke UniversityAcademic/Hospital1112010
Eastern Regional Medical CenterAcademic/Hospital1112013
Eden BiologicsFor profit1112018
Georgetown UniversityAcademic/Hospital1112011
Harvard UniversityAcademic/Hospital1112020
62 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGDec 30, 1993
GenentechFor profitNDADec 30, 1993