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ORKA-001
ORKA-001 is a Small molecule drug developed by Oruka Therapeutics, Inc.. It is currently in Phase 2 development.
ORKA-001 is a small molecule being studied in a Phase 1 clinical trial for its safety, tolerability, and pharmacokinetics in healthy volunteers and for the treatment of plaque psoriasis. The trial is a double-blind, placebo-controlled, single dose escalation study.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | ORKA-001 |
|---|---|
| Sponsor | Oruka Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis (PHASE2)
- An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis (PHASE2)
- Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis (PHASE2)
- ORKA-001 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:
- ORKA-001 CI brief — competitive landscape report
- ORKA-001 updates RSS · CI watch RSS
- Oruka Therapeutics, Inc. portfolio CI
Frequently asked questions about ORKA-001
What is ORKA-001?
Who makes ORKA-001?
What development phase is ORKA-001 in?
Related
- Manufacturer: Oruka Therapeutics, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing