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VRDN-003
VRDN-003 is a TSI-inhibiting monoclonal antibody Small molecule drug developed by Viridian Therapeutics, Inc.. It is currently in Phase 3 development for Graves' disease (hyperthyroidism).
VRDN-003 is a monoclonal antibody that targets and inhibits thyroid-stimulating immunoglobulin (TSI) to reduce autoimmune thyroid activation in Graves' disease.
VRDN-003 is a small molecule being studied in a clinical trial for the treatment of Thyroid Eye Disease (TED). The trial, NCT07155668, is evaluating the safety, tolerability, and pharmacokinetics of VRDN-003 in participants with TED.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | VRDN-003 |
|---|---|
| Sponsor | Viridian Therapeutics, Inc. |
| Drug class | TSI-inhibiting monoclonal antibody |
| Target | Thyroid-stimulating immunoglobulin (TSI) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Immunology |
| Phase | Phase 3 |
Mechanism of action
VRDN-003 binds to TSI, the pathogenic autoantibody responsible for thyroid overstimulation in Graves' disease, thereby blocking its interaction with the TSH receptor. By neutralizing TSI, the drug reduces thyroid hormone overproduction and associated hyperthyroid symptoms. This mechanism addresses the underlying autoimmune pathology rather than just symptom management.
Approved indications
- Graves' disease (hyperthyroidism)
Common side effects
- Injection site reactions
- Infusion-related reactions
- Upper respiratory tract infections
Key clinical trials
- A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (PHASE3)
- A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease (PHASE3)
- A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (PHASE3)
- An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) (PHASE3)
- An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VRDN-003 CI brief — competitive landscape report
- VRDN-003 updates RSS · CI watch RSS
- Viridian Therapeutics, Inc. portfolio CI
Frequently asked questions about VRDN-003
What is VRDN-003?
How does VRDN-003 work?
What is VRDN-003 used for?
Who makes VRDN-003?
What drug class is VRDN-003 in?
What development phase is VRDN-003 in?
What are the side effects of VRDN-003?
What does VRDN-003 target?
Related
- Drug class: All TSI-inhibiting monoclonal antibody drugs
- Target: All drugs targeting Thyroid-stimulating immunoglobulin (TSI)
- Manufacturer: Viridian Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Endocrinology / Immunology
- Indication: Drugs for Graves' disease (hyperthyroidism)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing