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Wockhardt Limited (IN:WOCKPHARMA)
:WOCKPHARMA
Zidebactam-Cefepime, Metronidazole, Fep-Zid
Pha1a
Phase I
Completed
A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
Jan 15, 2025
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Meropenem, Cefepime-Zidebactam (Fep-Zid)
Acute Pyelonephritis, Complicated Urinary Tract Infection
Phase III
Completed
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Jul 05, 2021
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3 G Or 6 G Zidebactam
Healthy Subjects
Phase I
Completed
MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults
Jan 25, 2016
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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 Wockhardt Limited (WOCKPHARMA) have in its pipeline
WOCKPHARMA is currently developing the following drugs: Zidebactam-Cefepime, Metronidazole, Fep-Zid, Meropenem, Cefepime-Zidebactam (Fep-Zid), 3 G Or 6 G Zidebactam. These drug candidates are in various stages of clinical development as the company works toward FDA approval.