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PYC Therapeutics Limited (AU:PYC)
:PYC
Pyc-001
Autosomal Dominant Optic Atrophy, Kjer Optic Atrophy, Opa1 Gene Mutation, Hereditary Optic Atrophies
Phase I/II
Recruiting
Safety of Single and Repeat Dose of PYC-001 Eye Injections in People With Autosomal Dominant Optic Atrophy
Apr 28, 2025
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Vp-001
Retinal Degeneration, Retinitis Pigmentosa 11, Retinal Disease, Eye Diseases Hereditary, Retinal Dystrophies
Phase I/II
Not Yet Recruiting
A Study of Two Doses of VP-001 Administered Intravitreally in Participants with Confirmed PRPF31 Mutation-Associated Retinal Dystrophy Previously Treated with VP001
Feb 20, 2025
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Pyc-003
Autosomal Dominant Polycystic Kidney Disease (Adpkd)
Phase I
Recruiting
Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
Nov 24, 2024
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Pyc-001
Autosomal Dominant Optic Atrophy, Kjer Optic Atrophy, Opa1 Gene Mutation, Hereditary Optic Atrophies
Phase I
Recruiting
SAD of IVT PYC-001 in OPA1 Mutation-Associated Autosomal Dominant Optic Atrophy (Sundew)
Jun 05, 2024
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Vp-001
Eye Diseases, Retinal Degeneration, Retinitis Pigmentosa 11, Retinal Disease, Retinal Dystrophies
Phase I
Recruiting
MAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects (Wallaby)
Jun 03, 2024
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Vp-001
Retinal Dystrophy, Prpf31 Mutationassociated Retinal Dystrophy, Rp11
Phase I
Active Not Recruiting
SAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects
May 25, 2023
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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 PYC Therapeutics Limited (PYC) have in its pipeline
PYC is currently developing the following drugs: Pyc-001, Vp-001, Pyc-003. These drug candidates are in various stages of clinical development as the company works toward FDA approval.