CDEK
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somatrogon

Trade name: Ngenla

Recombinant proteinapprovedOrphan Drug FDA

Approved

Jun 27, 2023

Clinical trial activity

2 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Jan 18, 2019 (NCT03810664)

Timeline

2010s

  1. Sep 29, 2010

    Orphan Drug Designation

  2. Jan 1, 2019

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2019

    Pfizer — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jun 27, 2023

    Pfizer — Earliest FDA Approval

  2. Jun 27, 2023

    Pfizer — Marketing Organization

  3. Jun 27, 2023

    Pfizer — NDA Secondary Org

  4. Jun 27, 2023

    Pfizer — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 27, 2023

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03831880Phase 3Feb 7, 2019Pfizer
NCT03810664Phase 1Jan 18, 2019Opko, QPS
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
OpkoFor profit1112019
PfizerFor profit1112019
QPSFor profit1012019
3 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
PfizerFor profitMKTGJun 27, 2023
PfizerFor profitNDA2Jun 27, 2023
PfizerFor profitNDAJun 27, 2023