thyrotropin alfa

Trade name: thyrogen

Recombinant proteinapprovedImaging agentOrphan Drug FDA

Approved

Nov 30, 1998

Thyroid-stimulating hormone (also known as thyrotropin, thyrotropic hormone, or abbreviated TSH) is a pituitary hormone that stimulates the thyroid gland to produce thyroxine (T4), and then triiodothyronine (T3) which stimulates the metabolism of almost every tissue in the body. It is a glycoprotein hormone produced by thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of the thyroid. — Wikipedia

Clinical trial activity

6 trials · 6 clinical orgs · 1 marketing orgs

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

Earliest trial started Dec 1, 1997 (NCT00001730)

Timeline

1990s

  1. Feb 24, 1992

    Orphan Drug Designation

  2. Nov 30, 1998

    Genzyme — Earliest FDA Approval

  3. Nov 30, 1998

    Genzyme — NDA Secondary Org

  4. Nov 30, 1998

    Genzyme — NDA Organization

2000s

  1. Jan 1, 2001

    Genzyme — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2019

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedNov 30, 1998

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

  • thyrogen
  • thyrogen
  • thyrogen
  • thyrotropin alfa
  • thyrotropin alfa
  • thyrotropin alfa
  • thyrotropin alfa
  • thyrotropin stimulated hormone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03841617Phase 2Jul 5, 2019National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT03276988Phase 1/Phase 2 (Phase 2)Sep 11, 2017Catholic University of Korea, Genexine, Inc., Symyoo
NCT01403324N/ASep 1, 2011Institut Gustave Roussy
NCT00295763Phase 3May 1, 2006Genzyme
NCT00196729Phase 3Dec 1, 2001Genzyme
NCT00001730Phase 4Dec 1, 1997National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenzymeFor profit2212001
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2221997
Catholic University of KoreaAcademic/Hospital1012017
Genexine, Inc.For profit1112017
Institut Gustave RoussyAcademic/Hospital1112011
SymyooFor profit1012017
6 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
GenzymeFor profitNDA2Nov 30, 1998
GenzymeFor profitNDANov 30, 1998