TEPEZZA (teprotumumab-trbw)
TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
How TEPEZZA Works
Teprotumumab-trbw functions by binding to the insulin-like growth factor-1 receptor (IGF-1R). By binding to this specific biological target, the drug blocks the receptor's activation and its subsequent signaling. While the exact mechanism in patients with Thyroid Eye Disease is not fully characterized, the therapeutic effect is driven by this inhibition of IGF-1R.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-01-21
- Patent Cliff
- 2027
- Revenue
- $457M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TEPEZZA Approval History
What TEPEZZA Treats
1 indicationsTEPEZZA is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thyroid Eye Disease
TEPEZZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07142642 | 20240181 | Ph 1 | completed | A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants |
| NCT06248619 | HZNP-TEP-305 | Ph 3 | active not recruiting | A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease |
| NCT05002998 | HZNP-TEP-402 2020-005999-36, 2024-515090-96-00 | Ph 4 | completed | TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study |
| NCT02103283 | DME01RV | Ph 1 | completed | A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME) |
| NCT01868997 results posted | TED01RV FD004792-01A1, 2014-000113-31 | Ph 2 | completed | Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease |
| NCT06674941 | HZNP-TEP-104 | Ph 1 | completed | A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants |
| NCT06563856 | HZNP-TEP-102 | Ph 1 | completed | A Study of TEPEZZA Subcutaneous Administration in Healthy Adults |
| NCT03298867 OPTIC results posted | HZNP-TEP-301 2017-002763-18 | Ph 3 | completed | Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study |
| NCT04583735 results posted | HZNP-TEP-403 | Ph 4 | completed | A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease |
| NCT04478994 results posted | HZNP-TEP-001 | Ph 1 | terminated | A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) |
| NCT03461211 OPTIC-X results posted | HZNP-TEP-302 2017-002713-58 | Ph 3 | completed | Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study |
| NCT06389578 | HZNP-TEP-103 | Ph 1 | completed | A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TEPEZZA FDA Label Details
Indications & Usage
FDA Label (PDF)TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
Pro Intelligence Preview
Deep insights for TEPEZZA
Revenue Insights
- • Q4-2025: $457M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment