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Tildacerfont
Polycystic Ovary Syndrome
Phase II
Terminated
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
May 06, 2022
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Tildacerfont
Congenital Adrenal Hyperplasia, 21-Ohd
Phase II
Terminated
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children with CAH
Oct 27, 2021
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Spr001
Congenital Adrenal Hyperplasia, Cah - Congenital Adrenal Hyperplasia, Cah - 21-Hydroxylase Deficiency
Phase II
Completed
Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
Sep 11, 2018
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Spr001
Congenital Adrenal Hyperplasia, Cah - Congenital Adrenal Hyperplasia
Phase II
Completed
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
Aug 15, 2017
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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 Spruce Biosciences (SPRB) have in its pipeline
SPRB is currently developing the following drugs: Tralesinidase Alfa, Tildacerfont, Tildacerfont. These drug candidates are in various stages of clinical development as the company works toward FDA approval.