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SPY002-091
SPY002-091 is a Small molecule drug developed by Spyre Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: SPY002.
SPY002 is a long-acting antibody being studied in a Phase 2 platform trial for the treatment of moderate to severe Ulcerative Colitis. The trial is assessing the efficacy and safety of SPY002 as a single agent and in combination with other long-acting antibodies.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | SPY002-091 |
|---|---|
| Also known as | SPY002 |
| Sponsor | Spyre Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis (PHASE2)
- A Study of SPY002-091 in Healthy Volunteers (PHASE1)
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:
- SPY002-091 CI brief — competitive landscape report
- SPY002-091 updates RSS · CI watch RSS
- Spyre Therapeutics, Inc. portfolio CI
Frequently asked questions about SPY002-091
What is SPY002-091?
Who makes SPY002-091?
Is SPY002-091 also known as anything else?
What development phase is SPY002-091 in?
Related
- Manufacturer: Spyre Therapeutics, Inc. — full pipeline
- Also known as: SPY002
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing