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Wockhardt USA LLC

🇺🇸United States
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

36

Active:0
Completed:28

Trial Phases

3 Phases

Phase 1:29
Phase 2:1
Phase 3:6

Drug Approvals

77

FDA:77

Drug Approvals

Sumatriptan Succinate

Approval Date
Dec 26, 2023
FDA

Abiraterone acetate

Approval Date
Nov 29, 2023
FDA

Oxacillin

Approval Date
Nov 22, 2023
FDA

Oxacillin

Approval Date
Nov 21, 2023
FDA

Acetaminophen

Approval Date
May 8, 2023
FDA

LIDOCAINE HYDROCHLORIDE

Approval Date
Mar 28, 2023
FDA

PROMETHAZINE HYDROCHLORIDE

Approval Date
Mar 22, 2023
FDA

Nicardipine Hydrochloride

Approval Date
Mar 11, 2023
FDA

Bupropion Hydrochloride

Approval Date
Dec 29, 2022
FDA
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Clinical Trials

Distribution across different clinical trial phases (36 trials with phase data)• Click on a phase to view related trials

Phase 1
29 (80.6%)
Phase 3
6 (16.7%)
Phase 2
1 (2.8%)

A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.

Phase 1
Recruiting
Conditions
PHA1A
Interventions
Drug: Zidebactam-Cefepime
First Posted Date
2025-02-04
Last Posted Date
2025-06-25
Lead Sponsor
Wockhardt
Target Recruit Count
30
Registration Number
NCT06806995
Locations
🇺🇸

Advanced Pharma CR, LLC, Miami, Florida, United States

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

Phase 1
Completed
Conditions
Bioavailability
Interventions
Drug: WCK 771 IV Infusion
Other: Placebo IV Infusion
First Posted Date
2022-12-07
Last Posted Date
2022-12-07
Lead Sponsor
Wockhardt
Target Recruit Count
36
Registration Number
NCT05640531
Locations
🇺🇸

PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200, Austin, Texas, United States

Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Phase 3
Completed
Conditions
Complicated Urinary Tract Infection
Acute Pyelonephritis
Interventions
Drug: Cefepime-zidebactam (FEP-ZID)
First Posted Date
2021-07-28
Last Posted Date
2025-02-07
Lead Sponsor
Wockhardt
Target Recruit Count
530
Registration Number
NCT04979806
Locations
🇺🇸

S&D Clinical Research, LLC, Fort Myers, Florida, United States

🇺🇸

Santos Research Center, Tampa, Florida, United States

🇧🇬

MHAT Dobrich AD, Dobrich, Bulgaria

and more 45 locations

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

Phase 1
Completed
Conditions
Pharmacokinetics
Interventions
Drug: WCK 2349 Oral
Other: Placebo Oral
First Posted Date
2021-05-05
Last Posted Date
2022-12-01
Lead Sponsor
Wockhardt
Target Recruit Count
36
Registration Number
NCT04874324

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

Phase 1
Completed
Conditions
Healthy
Interventions
Other: Placebo
First Posted Date
2019-06-11
Last Posted Date
2019-10-02
Lead Sponsor
Wockhardt
Target Recruit Count
10
Registration Number
NCT03981887
Locations
🇺🇸

Spaulding Clinical Research, West Bend, Wisconsin, United States

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News

India's ₹5,000 Crore PRIP Scheme Signals Major Shift from Generic Manufacturing to Innovation-Led Pharma Growth

India launches the ₹5,000 crore Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme, expected to attract ₹17,000 crore in additional R&D investment by end of 2025.

Senores Pharmaceuticals Acquires ANDA for Enalapril Maleate Tablets from Wockhardt

Senores Pharmaceuticals has acquired the US FDA-approved ANDA for enalapril maleate tablets in multiple dosages from Wockhardt, expanding its presence in the hypertension treatment market.

Wockhardt's Novel Antibiotic 'Zaynich' Expected to Receive USFDA Approval in 2025

Wockhardt's novel antibiotic Zaynich, a combination of Zidebactam and Cefepime targeting multi-drug resistant Gram-negative infections, is anticipated to receive USFDA approval next year.

Wockhardt's Miqnaf (Nafithromycin) Receives CDSCO Approval for CABP Treatment in Adults

Wockhardt's Miqnaf (Nafithromycin) has been approved by CDSCO for treating community-acquired bacterial pneumonia (CABP) in adults, offering a new treatment option.

Wockhardt's Zaynich Demonstrates Superior Efficacy in Phase III cUTI Trial

Wockhardt's Zaynich (zidebactam/cefepime) achieved superiority over meropenem in a Phase III trial for complicated urinary tract infections (cUTI).

Wockhardt's Antibacterial Drug Zaynich Shows Promise in Treating US Cancer Patient with Resistant Infections

• Wockhardt's drug Zaynich (WCK 5222) successfully treated a US cancer patient with infections caused by highly resistant bacteria, facilitating a transplant. • The drug effectively neutralized resistance mechanisms like IMP, NDM, and OXA-48 in Pseudomonas aeruginosa and Klebsiella pneumoniae. • Zaynich is nearing completion of Phase III trials for global registration, with potential availability in global markets by 2026. • Compassionate use of Zaynich has benefited 45 patients to date, addressing unmet needs for antibacterial drugs against superbugs.

Advancements in Complicated Urinary Tract Infection (cUTI) Therapeutics

• Several pharmaceutical and biotech companies are actively developing novel therapies for complicated urinary tract infections (cUTIs). • Spero Therapeutics' Tebipenem Pivoxil Hydrobromide is in Phase III clinical trials, representing a late-stage advancement in cUTI treatment. • Other companies like Iterum Therapeutics and Venatorx are also contributing to the cUTI therapeutics market with drugs like Sulopenem. • Emerging therapies cover various routes of administration, molecule types, and mechanisms of action, offering diverse treatment options.

India Launches First Indigenous Antibiotic Nafithromycin to Combat Drug-Resistant Pneumonia

India has launched Nafithromycin, its first indigenously developed macrolide antibiotic, to combat antimicrobial resistance (AMR).

India Launches Nafithromycin, First Indigenous Antibiotic to Combat Antimicrobial Resistance

Nafithromycin, India's first indigenously developed antibiotic, has been launched to combat antimicrobial resistance (AMR).

India's Nafithromycin Offers New Hope Against Drug-Resistant Pneumonia

Nafithromycin, India's first indigenous antibiotic, targets drug-resistant community-acquired bacterial pneumonia (CABP) and offers a new treatment option.

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