Solasia Pharma KK (9SO) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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) | Phase I | Healthy Volunteers | Completed | Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites | Sep 21, 2021 | ― |
| Calmangafodipir (5 Μmol/Kg) | Phase III | Colorectal Cancer, Chemotherapy-Induced Peripheral Neuropathy | Terminated | Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer | May 14, 2019 | ― |
| Calmangafodipir (5 Μmol/Kg), Calmangafodipir (2 Μmol/Kg) | Phase III | Colorectal Cancer, Chemotherapy-Induced Peripheral Neuropathy | Terminated | Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) | Aug 29, 2018 | ― |
| Sp-02L (Darinaparsin For Injection) | Phase II | Peripheral T-Cell Lymphoma | Completed | A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) | Dec 25, 2015 | ― |
| Sp-01 (Granisetron Transdermal Delivery System), Granisetron Hydrochloride Tablet | Phase III | Chemotherapy-Induced Nausea And Vomiting | Completed | A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting | Sep 03, 2013 | ― |
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
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 (DE:9SO) have in its pipeline
Solasia Pharma KK DE:9SO 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), Sp-02L (Darinaparsin For Injection), Sp-01 (Granisetron Transdermal Delivery System), Granisetron Hydrochloride Tablet. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
