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4SC AG (GB:0R6U)
:0R6U
[14C]-Resminostat
Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
Phase I
Completed
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
Jun 23, 2021
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Domatinostat In Combination With Avelumab
Merkel Cell Carcinoma
Phase II
Withdrawn
Domatinostat in Combination With Avelumab in Patients With Treatment-naïve Metastatic Merkel Cell Carcinoma (MERKLIN 1)
Apr 15, 2021
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Domatinostat In Combination With Avelumab
Merkel Cell Carcinoma
Phase II
Completed
Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
May 12, 2020
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4Sc-202 In Combination With Pembrolizumab
Malignant Melanoma
Phase I/II
Completed
4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
Sep 05, 2017
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Resminostat
Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
Phase II
Completed
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
Oct 26, 2016
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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 4SC AG (0R6U) have in its pipeline
0R6U is currently developing the following drugs: [14C]-Resminostat, Domatinostat In Combination With Avelumab, Domatinostat In Combination With Avelumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.