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Oruka Therapeutics (ORKA)
NASDAQ:ORKA
Orka-001
Plaque Psoriasis
Phase II
Recruiting
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Dec 16, 2025
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Orka-002
Healthy Volunteers
Phase I
Active Not Recruiting
ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose
Apr 15, 2025
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Orka-001
Healthy Volunteers
Phase I
Active Not Recruiting
ORKA-001 in Healthy Volunteers
Nov 13, 2024
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Oruka Therapeutics (ORKA) have in its pipeline
ORKA is currently developing the following drugs: Orka-001, Orka-001 Induction Dose, Orka-001 Maintenance Dose, Orka-002. These drug candidates are in various stages of clinical development as the company works toward FDA approval.