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poractant alfa

Trade name: curosurf

Animal productapprovedOrphan Drug FDA

Approved

Nov 18, 1999

Poractant alfa is a pulmonary surfactant sold under the brand name Curosurf by Chiesi Farmaceutici. Poractant alfa is an extract of natural porcine lung surfactant. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa. The new generic form of surfactant is Varasurf developed in PersisGen Co. and commercialized by ArnaGen Pharmad. It has fully comparable quality profile with Curosurf. — Wikipedia

Clinical trial activity

24 trials · 64 clinical orgs · 2 marketing orgs

Phase 1
1
Phase 2
8
Phase 3
5
Phase 4
8

Earliest trial started Jan 1, 2005 (NCT00767039)

Timeline

1990s

  1. Aug 2, 1993

    Orphan Drug Designation

  2. Nov 18, 1999

    Dey — Earliest FDA Approval

  3. Nov 18, 1999

    Dey — NDA Organization

  4. Nov 18, 1999

    Chiesi — NDA Secondary Org

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2016

    Chiesi — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2019

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Surfactant agent

    Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces

  • Tumor antigensSurfactant

    Tumor antigens surfactant

    Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces

Approval history

  • approvedNov 18, 1999

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • cadisurf
  • curosurf
  • curosurf
  • curosurf
  • curosurf
  • poractant
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa
  • poractant alfa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07261787Phase 4Dec 1, 2025Medical University of Graz
NCT06007547Phase 4Nov 1, 2023Chiesi, Endeavor Health, University of Chicago
NCT04862377Phase 3Oct 1, 2021University of Barcelona
NCT04825197Phase 2Aug 1, 2021Hospital Agostino Gemelli, Universita' Cattolica del Sacro Cuore
NCT04502433Phase 2Sep 1, 2020Chiesi, University of London
NCT04315636Phase 3Jun 30, 2020University of Zurich
NCT04384731Phase 2May 27, 2020Hospital of Mantes-la-Jolie, France, University Hospital, Tours, University of Versailles
NCT04199364Phase 4Jan 1, 2020Marche Polytechnic University
NCT04181255Phase 1Dec 31, 2019Chiesi, University of Michigan
NCT02772081Phase 3Jun 1, 2018Buzzi Hospital Milan, Chiesi, IQVIA
NCT03521063Phase 4Jan 1, 2018Universidad Autonoma de San Luis Potosi
NCT02774044Phase 2/Phase 3 (Phase 3)Jun 1, 2016All India Institute of Medical Sciences, Azad University, Chacha Nehru Bal Chikitsalaya, New Delhi, Government Medical College, Chandigarh, Hospital for Children, Chennai, Jawaharlal Institute of Postgraduate Medical Education and Research, King Edward Memorial Hospital, Mumbai, Lady Hardinge Medical College, Lokmanya Tilak Municipal Medical College, Postgraduate Institute of Medical Education and Research, Rajiv Gandhi University of Health Sciences, Wellcome Trust
NCT02452476Phase 2Jan 1, 2016Chiesi, Parexel, Tufts University
NCT02482766N/ANov 1, 2015Azienda Ospedaliera San Gerardo di Monza, Catholic University of Sacred Heart, Rome, Centre for Neonatal Research and Education, Crawley, West Australia, Marche Polytechnic University, Monash University, University of Amsterdam, University of Florence, University of Milan
NCT01941524Phase 4Sep 1, 2013Poznan University
NCT02834624N/AJul 1, 2013University of Missouri
NCT01709409Phase 3Mar 1, 2013University of Ottawa
NCT01537354N/AJun 1, 2012Rafael Pharmaceuticals Inc., University of Michigan
NCT01852461N/AAug 1, 2011Dr. Sami Ulus Children's Hospital, Sami Ulus Maternity and Childrens Hospital
NCT01860014N/AMar 1, 2010Dr. Sami Ulus Children's Hospital, Zekai Tahir Burak Hospital
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (64)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ChiesiFor profit7442007
Dr. Sami Ulus Children's HospitalAcademic/Hospital2212010
Marche Polytechnic UniversityAcademic/Hospital2122015
University of MichiganAcademic/Hospital2222012
All India Institute of Medical SciencesAcademic/Hospital1112016
ARAIRLORAcademic/Hospital1012009
Azad UniversityAcademic/Hospital1012016
Azienda Ospedaliera San Gerardo di MonzaAcademic/Hospital1012015
Boston UniversityAcademic/Hospital1112005
Buzzi Hospital MilanAcademic/Hospital1012018
Catholic University of Sacred Heart, RomeAcademic/Hospital1112015
Centre for Neonatal Research and Education, Crawley, West AustraliaAcademic/Hospital1012015
Chacha Nehru Bal Chikitsalaya, New DelhiAcademic/Hospital1012016
Endeavor HealthAcademic/Hospital1112023
German Federal Ministry of Education and ResearchGovernment1012009
Government Medical College, ChandigarhAcademic/Hospital1012016
Hospital Agostino GemelliAcademic/Hospital1112021
Hospital for Children, ChennaiAcademic/Hospital1012016
Hospital of LeverkusenAcademic/Hospital1012009
Hospital of Mantes-la-Jolie, FranceAcademic/Hospital1012020
64 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
ChiesiFor profitNDA2Nov 18, 1999
DeyFor profitNDANov 18, 1999