Drugs / Teprotumumab
Teprotumumab
also known as
IBI311 · RG1507 · Tepezza · Teprotumumab N01 · R1507 · HZN-001 · RO-4858696 · RO-4858696-000 · +3 more
Monoclonal antibody targets IGF1R via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tepezza | — | 2025-06-19 | europa.eu ↗ |
| Approved | US (FDA) | TEPEZZA | — | 2020-01-21 | fda.gov ↗ |
Trials 27 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06866548 | Mar → Nov 2025 overdue | castration-resistant prostate carcinoma | Shanghai Changzheng Hospital | Active not recruiting | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT07142642 | Aug → Nov 2025 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06674941 | Mar → Nov 2023 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT05480579 | Aug → Nov 2022 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06389578 | Jul 2022 → Feb 2023 | disease of orbital part of eye adnexa | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT06563856 | Sep 2020 → May 2021 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT02103283 | Oct 2014 → Aug 2016 | diabetic macular edema | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00985374 | Nov 2009 → Jun 2013 | neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT00882674 | Jul 2009 → Dec 2010 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00811993 | Feb 2009 → Dec 2012 | neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT00560144 | Dec 2007 → Dec 2011 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00400361 | Apr 2006 → Apr 2011 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07594912 | Aug 2026 → Dec 2027 expected | disease of orbital part of eye adnexa, optic nerve disorder | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01868997 | Jul 2013 → Mar 2016 | disease of orbital part of eye adnexa | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00796107 | Jan 2009 → Mar 2010 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2 | NCT00760929 | Nov 2008 → Jun 2010 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2 | NCT00773383 | Nov 2008 → Feb 2010 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2 | NCT00642941 | Dec 2007 → Feb 2014 | sarcoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07113262 | Sep 2025 → Dec 2026 expected | endocrine exophthalmos | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06248619 | Jul 2024 → Dec 2025 overdue | endocrine exophthalmos | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06126783 | Oct 2023 → Sep 2025 | disease of orbital part of eye adnexa | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03461211 | Apr 2018 → Jun 2020 | endocrine exophthalmos | Amgen | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07308964 | Jan 2026 → Jan 2028 expected | disease of orbital part of eye adnexa | Sheba Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07265258 | Dec 2025 → Sep 2026 expected | endocrine exophthalmos | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05002998 | Sep 2021 → Dec 2025 | endocrine exophthalmos | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04583735 | Sep 2021 → Mar 2023 | endocrine exophthalmos | Amgen | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04040894 | — | disease of orbital part of eye adnexa | Amgen | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04478994 Comparator | Nov 2021 → Nov 2022 | diffuse cutaneous systemic sclerosis | Amgen | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06525506 Comparator | Sep 2024 → Jan 2025 | endocrine exophthalmos | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05795621 Comparator | Feb → Dec 2023 | endocrine exophthalmos | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06269393 Comparator | Jan 2024 → Apr 2025 | disease of orbital part of eye adnexa | Peking University People's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03298867 Comparator | Oct 2017 → Feb 2019 | endocrine exophthalmos | Amgen | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07152392 Comparator | Apr 2025 → Jul 2027 expected | disease of orbital part of eye adnexa | Shanghai Changzheng Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07152340 Comparator | Apr 2025 → Apr 2027 expected | disease of orbital part of eye adnexa | Shanghai Changzheng Hospital | Recruiting | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-06 | Amgen | AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR SUBCUTANEOUS TEPEZZA® IN ADULTS LIVING WITH MODERATE-TO-SEVERE ACTIVE THYROID EYE DISEASE amgen.com ↗ |
| 2024-09-24 | Amgen | TEPEZZA® (TEPROTUMUMAB) RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ACTIVE THYROID EYE DISEASE amgen.com ↗ |
| 2024-04-26 | Amgen | AMGEN TO SUBMIT TEPROTUMUMAB MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY amgen.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Teprotumumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04040894 ↗ |
| Known as | HZN-001 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743079 ↗ |
| Known as | IBI311 | “anti-IGF-1R mAb (Teprotumumab/IBI311)” NCT06866548 ↗ |
| Known as | R1507 | “R1507 is a selective, fully human, recombinant monoclonal antibody (immunoglobulin G1 subclass) against insulin-like growth factor-1 receptor (IGF-1R).” PMID 22025157 ↗ Oct 20111“IGF-1R Antagonist R1507” NCT00811993 ↗ |
| Known as | RG1507 | “Drug: RG1507” NCT00642941 ↗ |
| Known as | RO-4858696 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743079 ↗ |
| Known as | RO-4858696-000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743079 ↗ |
| Known as | RV-001 MONOCLONAL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743079 ↗ |
| Known as | Tepezza | “Teprotumumab Injection [Tepezza]” NCT07308964 ↗ |
| Known as | Teprotumumab N01 | “Teprotumumab N01 injection (code name IBI311)” NCT07113262 ↗ |
| Known as | Teprotumumab-trbw | “TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study” NCT05002998 ↗ |
| Known as | Tetuzumab | “Tetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody.” NCT07152340 ↗ |
| Action | Inhibit | “Insulin-Like Growth Factor-1 Receptor-Blocking Antibody” PMID 33768488 ↗ Mar 2021 |
| Modality | Monoclonal antibody | “R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor” PMID 22025149 ↗ Oct 2011 |
| Route | Intravenous | “Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).” NCT00400361 ↗ |
| Target | IGF1R | “R1507, a monoclonal antibody to the insulin-like growth factor 1 receptor” PMID 22025149 ↗ Oct 2011 |