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Ascendis Pharma (ASND)
NASDAQ:ASND
Lonapegsomatropin [Skytrofa®], Somatropin Pen Injector
Turner Syndrome, Idiopathic Short Stature, Short Stature Homeobox Gene Mutation, Small For Gestational Age At Delivery
Phase III
Recruiting
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Oct 14, 2025
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Navepegritide
Achondroplasia
Phase II
Recruiting
A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.
Dec 10, 2024
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Navepegritide
Achondroplasia
Phase II
Recruiting
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia
Oct 06, 2023
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Pembrolizumab, Transcon Tlr7/8 Agonist, Transcon Il-2 Β/Γ
Head And Neck Neoplasms
Phase II
Terminated
TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
Jul 20, 2023
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Transcon Cnp
Achondroplasia
Phase II
Active Not Recruiting
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia
Feb 09, 2022
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Transcon Hgh, Daily Hgh
Hormones, Pituitary Disease, Anterior, Pituitary Diseases, Growth Hormone Deficiency, Endocrine System Diseases
Phase III
Unknown
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
Mar 26, 2020
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Transcon Cnp
Achondroplasia
Phase II
Completed
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
Sep 09, 2019
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Transcon Pth
Endocrine System Diseases, Hypoparathyroidism, Parathyroid Diseases
Phase II
Completed
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
Jun 20, 2019
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Transcon Treprostinil
Healthy Volunteers
Phase I
Terminated
A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers
Jan 10, 2019
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Transcon Hgh
Endocrine System Diseases, Pituitary Diseases, Growth Hormone Deficiency, Pediatric, Hormone Deficiency
Phase III
Completed
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
Nov 14, 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 Ascendis Pharma (ASND) have in its pipeline
ASND is currently developing the following drugs: Lonapegsomatropin [Skytrofa®], Somatropin Pen Injector, Navepegritide, Navepegritide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.