Drug · Monoclonal Antibody

Teprotumumab

CI-DRUG-00000586Explore in graph →NCIt C95797 CHEMBL1743079 CIViC Approved

Regulatory

Approvals (1)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease ( 1 )	approved	Jan 21, 2020	openfda

Data updated 17 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 2	9	1	US	Jan 21, 2020	2006-04
Malignant Breast Neoplasm	Phase2	Phase 2	2	0	—	—	Jan 28, 2009
Malignant Lung Neoplasm	Phase2	Phase 2	2	0	—	—	2008-11

Computedclinicaltrials

Curated evidence

Clinical evidence (3)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PTPRD V253I1
Cixutumumab + Teprotumumab

Clinical trials

Trials with this intervention (9)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–9 of 9 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00642941	A Study of R1507 in Participants With Recurrent or Refractory Sarcoma	terminated	Phase 2	317	Hoffmann-La RocheINDUSTRY	11	Feb 3, 2021	clinicaltrials
NCT00760929	A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).	terminated

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Insulin-like growth factor I receptor antagonist
Targets: 1 gene
UNII: Y64GQ0KC0A
Aliases: Anti-IGF-1R Monoclonal Antibody R1507, HZN-001, HZN001, Immunoglobulin G1, Anti-(Human Insulin-like Growth Factor I Receptor)(Human Monoclonal Heavy Chain), Disulfide With Human Monoclonal Light Chain, Dimer, Onilcamotide, R-1507, R1507, RG-1507, RG1507, Rhoc peptide vaccine rv001v, RO-4858696, RO4858696, RO-4858696-000, RO-4858696000, RO4858696-000, RV-001, RV001, RV001 Monoclonal, RV-001 MONOCLONAL, RV001 MONOCLONAL, Tepezza, Teprotumumab, Teprotumumab trbw

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (0)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

Data not yet available

No cross-reference code recorded yet beyond the record identifiers above.

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

KRAS Mutation2
Erlotinib + TeprotumumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID3713 In advanced-stage (IIIB or IV) non-small cell lung cancer patients treated with erlotinib daily and teprotumumab (R1507) weekly or every three weeks, patients whose tumors harbored KRAS mutations had … (full text at CIViC) PMID 22025157 · Ramalingam et al., 2011 · Open in CIViC	civic
Selumetinib + TeprotumumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1004 Preclinial data from KRAS mutant colorectal cancer cell lines show syngergistic effect on cell viability and apoptosis in vitro and in vivo when MEK and IGF-IR are inhibited concomitantly. In other ce… (full text at CIViC) PMID 21985784 · Ebi et al., 2011 · Open in CIViC	civic