Education
About Us
Working with TipRanks
Follow Us
Hikma Pharma (HKMPY)
:HKMPY
Vesicare (Solifenacin Succinate 5 Mg) & Betmiga (Mirabegron 50 Mg) (Reference First Dose), Mirfenacin Mr (Solifenacin Succinate 5 Mg & Mirabegron 50 Mg) (Test), Vesicare (Solifenacin Succinate 5 Mg) & Betmiga (Mirabegron 50 Mg) (Reference Second Dose)
Healthy
Phase I
Completed
Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)
Feb 21, 2023
―
Empagliflozin & Metformin (Test), Empagliflozin & Metformin (Reference)
Healthy
Phase I
Completed
Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)
Nov 16, 2021
―
Topoprazan, Takecab
Healthy
Phase I
Completed
Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
Nov 14, 2021
―
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 Hikma Pharma (HKMPY) have in its pipeline
HKMPY is currently developing the following drugs: Vesicare (Solifenacin Succinate 5 Mg) & Betmiga (Mirabegron 50 Mg) (Reference First Dose), Mirfenacin Mr (Solifenacin Succinate 5 Mg & Mirabegron 50 Mg) (Test), Vesicare (Solifenacin Succinate 5 Mg) & Betmiga (Mirabegron 50 Mg) (Reference Second Dose), Empagliflozin & Metformin (Test), Empagliflozin & Metformin (Reference), Topoprazan, Takecab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.