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Fortrea Holdings Inc. (FTRE)
NASDAQ:FTRE
Geh300079 (68Ga) Injection Positron-Emission Tomography (Pet)/Computed Tomography (Ct)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Gastric Cancers, Ovarian Cancers
Phase II/III
Not Yet Recruiting
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
Oct 09, 2025
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D3s-001
Healthy Adult Volunteers
Phase I
Recruiting
A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants
Jul 10, 2025
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Ap301, Ap301 Low Dose
Hyperphosphatemia, Dialysis, Chronic Kidney Disease, Receiving Dialysis, Esrd (End-Stage Renal Disease)
Phase III
Recruiting
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Mar 19, 2025
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Givinostat Hydrochloride, Givinostat Hydrochloride - Cohort 2
Duchenne Muscular Dystrophy
Phase II
Recruiting
Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old
Dec 11, 2024
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Ath-1105
Healthy Volunteers
Phase I
Completed
A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
May 17, 2024
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Geh200520 Injection And Geh200521 (18F) Injection, Static - Pet/Ct Scan
Healthy Volunteers
Phase I
Recruiting
A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers
Apr 23, 2024
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Givinostat
Duchenne Muscular Dystrophy
Phase III
Recruiting
Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy
Jun 16, 2023
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Altropane (123I) Injection
Parkinson Disease, Movement Disorders
Phase II
Terminated
Altropane Dose for Imaging Patients With Suspected Parkinson's Disease
Nov 01, 2022
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leniolisib
Apds
Phase III
Active Not Recruiting
Pediatric Patients Aged 1 to 6 Years With APDS
Oct 17, 2022
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leniolisib
Apds
Phase III
Active Not Recruiting
Pediatric Patients Aged 4 to 11 Years With APDS
May 20, 2022
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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 Fortrea Holdings Inc. (FTRE) have in its pipeline
FTRE is currently developing the following drugs: Geh300079 (68Ga) Injection Positron-Emission Tomography (Pet)/Computed Tomography (Ct), D3s-001, Ap301, Ap301 Low Dose. These drug candidates are in various stages of clinical development as the company works toward FDA approval.