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Solasia Pharma KK (JP:4597)
:4597
Sp-01 Manufactured By Site K (Sp-01-K, Transdermal Patch Contained Granisetron), Sp-01 Manufactured By Site A (Sp-01-A, Transdermal Patch Contained Granisetron)
Healthy Volunteers
Phase I
Completed
Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites
Sep 21, 2021
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Calmangafodipir (5 Μmol/Kg)
Colorectal Cancer, Chemotherapy-Induced Peripheral Neuropathy
Phase III
Terminated
Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer
May 14, 2019
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Calmangafodipir (5 Μmol/Kg), Calmangafodipir (2 Μmol/Kg)
Colorectal Cancer, Chemotherapy-Induced Peripheral Neuropathy
Phase III
Terminated
Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)
Aug 29, 2018
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Sp-02L (Darinaparsin For Injection)
Peripheral T-Cell Lymphoma
Phase II
Completed
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Dec 25, 2015
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Sp-01 (Granisetron Transdermal Delivery System), Granisetron Hydrochloride Tablet
Chemotherapy-Induced Nausea And Vomiting
Phase III
Completed
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
Sep 03, 2013
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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 Solasia Pharma KK (4597) have in its pipeline
4597 is currently developing the following drugs: Sp-01 Manufactured By Site K (Sp-01-K, Transdermal Patch Contained Granisetron), Sp-01 Manufactured By Site A (Sp-01-A, Transdermal Patch Contained Granisetron), Calmangafodipir (5 Μmol/Kg), Calmangafodipir (5 Μmol/Kg), Calmangafodipir (2 Μmol/Kg). These drug candidates are in various stages of clinical development as the company works toward FDA approval.