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Heidelberg Pharma AG (DE:HPHA)
XETRA:HPHA
Hdp-101
Multiple Myeloma, Plasma Cell Disorder
Phase I/II
Recruiting
Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Apr 23, 2021
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Iodine (124I) Girentuximab
Renal Cell Carcinoma, Kidney Cancer
Phase III
Withdrawn
REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT
Dec 19, 2012
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124-Iodine-Cg250 (124I-Cg250), Ct
Renal Cell Carcinoma, Kidney Cancer
Phase III
Completed
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
Jan 21, 2008
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Girentuximab
Kidney Cancer
Phase III
Completed
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Jul 08, 2004
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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 Heidelberg Pharma AG (HPHA) have in its pipeline
HPHA is currently developing the following drugs: Hdp-101, Iodine (124I) Girentuximab, 124-Iodine-Cg250 (124I-Cg250), Ct. These drug candidates are in various stages of clinical development as the company works toward FDA approval.