teprotumumab
Trade name: Tepezza
Approved
Jan 21, 2020
Teprotumumab, sold under the brand name Tepezza, is a medication used to treat thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards. It is a human monoclonal antibody developed by Genmab and Roche for tumor treatment but was later developed by River Vision Development Corporation and Horizon Therapeutics to be used for ophthalmic uses. It binds to IGF-1R. — Wikipedia
Clinical trial activity
25 trials · 13 clinical orgs · 1 marketing orgs
Earliest trial started Apr 1, 2006 (NCT00400361)
Timeline
2010s
- May 6, 2013
Orphan Drug Designation
- Jan 1, 2017
Earliest Phase 3 Sponsor(trial)
2020s
- Jan 21, 2020
Horizon Therapeutics, LLC — Earliest FDA Approval
- Jan 21, 2020
Horizon Therapeutics, LLC — Marketing Organization
- Jan 21, 2020
Horizon Therapeutics, LLC — NDA Secondary Org
- Jan 21, 2020
Horizon Therapeutics, LLC — NDA Organization
Indications
Approved for
Studied for
- Biological Availability · Phase 1
- Breast Neoplasms · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Graves Ophthalmopathy · Phase 4
- Healthy Volunteers · Phase 1
- Macular Edema · Phase 1
- Neoplasms · Phase 1
- Prostatic Neoplasms · Early Phase 1
- Sarcoma · Phase 2
- Scleroderma, Diffuse · Phase 1
- Therapeutic Equivalency · Phase 1
- Thyroid Gland · Phase 4
Mechanism of action
- IGF-like family receptor 1ANTAGONIST
IGFLR1 antagonist
- Insulin-like growth factor I receptorANTAGONIST
IGF1R antagonist
Antibody binding results in endosomal degradation of IGF-1R and inhibition of receptor-mediated signaling.
Approval history
- approvedPriority reviewFast trackBreakthroughJan 21, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTeprotumumab ↗
- NCATSY64GQ0KC0A ↗
- ChEMBLCHEMBL1743079 ↗
Also known as
- r1507
- r 1507
- r-1507
- r-1507
- r-1507
- r-1507 monoclonal antibody
- rg1507
- rg1507
- rg 1507
- rg-1507
- rg-1507
- rg-1507 monoclonal antibody
- ro-4858696
- ro-4858696000
- teprotumumab
- teprotumumab
- teprotumumab
- teprotumumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07308964 | Phase 4 | Jan 31, 2026 | Tel Aviv University |
| NCT07265258 | Phase 4 | Dec 30, 2025 | Innovent Biologics (Suzhou) Co. Ltd. |
| NCT07142642 | Phase 1 | Aug 26, 2025 | Amgen |
| NCT06866548 | Early Phase 1 (Phase 1) | Mar 10, 2025 | Second Military Medical University |
| NCT06248619 | Phase 3 | Jul 5, 2024 | Amgen |
| NCT06674941 | Phase 1 | Mar 24, 2023 | Amgen |
| NCT06389578 | Phase 1 | Jul 14, 2022 | Amgen |
| NCT05002998 | Phase 4 | Aug 31, 2021 | Horizon Therapeutics, LLC |
| NCT04478994 | Phase 1 | Nov 30, 2020 | Horizon Therapeutics, LLC |
| NCT04583735 | Phase 4 | Oct 31, 2020 | Horizon Therapeutics, LLC |
| NCT06563856 | Phase 1 | Sep 22, 2020 | Amgen |
| NCT03461211 | Phase 3 | Apr 16, 2018 | Cedars-Sinai Medical Center, Horizon Pharma, Johannes Gutenburg University |
| NCT03298867 | Phase 3 | Oct 24, 2017 | Cedars-Sinai Medical Center, Horizon Pharma, Johannes Gutenburg University |
| NCT02103283 | Phase 1 | Oct 1, 2014 | Retina Vitreous Associates Beverley Hills, California, River Vision Development Corporation |
| NCT01868997 | Phase 2 | Jul 1, 2013 | River Vision Development Corporation, University of Michigan |
| NCT00985374 | Phase 1 | Nov 1, 2009 | Roche |
| NCT00882674 | Phase 1 | Jul 1, 2009 | Roche |
| NCT00811993 | Phase 1 | Feb 1, 2009 | Roche |
| NCT00796107 | Phase 2 | Jan 1, 2009 | Roche |
| NCT00773383 | Phase 2 | Nov 1, 2008 | Roche |
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 9 | 9 | 2 | 2006 |
| Amgen | For profit | 5 | 5 | 2 | 2020 |
| Horizon Pharma | For profit | 3 | 3 | 2 | 2017 |
| Horizon Therapeutics, LLC | For profit | 3 | 3 | 2 | 2020 |
| Cedars-Sinai Medical Center | Academic/Hospital | 2 | 0 | 1 | 2017 |
| Johannes Gutenburg University | Academic/Hospital | 2 | 0 | 1 | 2017 |
| River Vision Development Corporation | For profit | 2 | 2 | 2 | 2013 |
| Innovent Biologics (Suzhou) Co. Ltd. | For profit | 1 | 1 | 1 | 2025 |
| Retina Vitreous Associates Beverley Hills, California | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Sarcoma Alliance for Research through Collaboration | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Second Military Medical University | Government | 1 | 1 | 1 | 2025 |
| Tel Aviv University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| University of Michigan | Academic/Hospital | 1 | 0 | 1 | 2013 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Horizon Therapeutics, LLC | For profit | MKTG | Jan 21, 2020 |
| Horizon Therapeutics, LLC | For profit | NDA2 | Jan 21, 2020 |
| Horizon Therapeutics, LLC | For profit | NDA | Jan 21, 2020 |