COMPANY

Wockhardt

FDA-approved therapeutic company Clinical Phase 3

Keywords: infectious disease Acute Pyelonephritis Type I Diabetes Diabetes Complicated Urinary Tract Infection PHA1A Renal Impairment Diabetes Mellitus Complicated Urinary Tract Infections Acute Bacterial Skin and Skin Structure Infections Community-Acquired Bacterial Pneumonia Antibiotics Causing Adverse Effects in Therapeutic Use Serious Gram-negative Infections Hepatic Impairment Variation in Qt Interval Intrapulmonary Pharmacokinetics of WCK 2349 Effect of Food Type1 Diabetes WCK 4873 WCK 2349 Nafithromycin WCK 5222 WCK 771 FEP-ZID

Profile checked Oct 10, 2026

38Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Sep 30, 2026 Trial start 2: This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Comp source ↗
May 29, 2026 FDA FDA New drug/biologic (novel): ZAYNICH (cefepime hydrochloride; zidebactam) — NDA220787, May 29, 2026. Applicant at approval: Wockhardt BIO AG. source ↗
Jan 21, 2025 Trial start Phase 1: A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination. source ↗
2024-01 Trial start Phase 3: Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) source ↗
Aug 28, 2022 Trial start Phase 3: Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) source ↗
Jun 18, 2019 Trial start Phase 1: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin source ↗
Mar 23, 2018 Trial start Phase 1: To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) source ↗
Dec 13, 2017 Trial start Phase 1: Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion. source ↗
Aug 25, 2017 Trial start Phase 3: Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) source ↗
Mar 31, 2017 Trial start Phase 1: Plasma and Intrapulmonary Concentrations Study of WCK 5222 source ↗
Feb 9, 2017 Trial start Phase 1: Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers source ↗
Nov 18, 2016 Trial start II: Phase II Study of Oral Nafithromycin in CABP source ↗
Oct 25, 2016 Trial start Phase 1: To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment source ↗
Apr 25, 2016 Trial start 1: A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects source ↗
2016-03 Trial start Phase 1: A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment source ↗
2016-03 Trial start Phase 1: MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers source ↗
2016-02 Trial start Phase 1: MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults source ↗
2015-08 Trial start Phase 1: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime source ↗
2015-04 Trial start Phase 1: Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects source ↗
2014-09 Trial start Phase 1: Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment source ↗
2014-09 Trial start Phase 1: Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects source ↗
2014-08 Trial start Phase 1: Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers source ↗
Aug 20, 2013 Trial start Phase 1: Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers source ↗
2013-06 Trial start I: Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers source ↗
Mar 14, 2013 Trial start Phase 1: The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers source ↗

Showing 25 of 37 dated events.

Upcoming milestones

Sep 1, 2027 (ESTIMATED) · 2 · This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complic · NCT07840105

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 38

Record	Title	Phase	Status	Start	Primary completion
NCT07840105	This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis	2	Not yet recruiting	Sep 30, 2026	Sep 1, 2027 (estimated)
NCT04979806	Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)	Phase 3	Completed	Aug 28, 2022	Nov 25, 2024 (actual)
NCT07247942	Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.	Phase 1	Completed	Dec 13, 2017	Jan 20, 2018 (actual)
NCT02674347	MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults	Phase 1	Completed	2016-02	2016-04 (actual)
NCT06806995	A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.	Phase 1	Completed	Jan 21, 2025	Feb 17, 2025 (actual)
NCT03630081	Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)	Phase 3	Unknown status (ClinicalTrials.gov)	2024-01	2026-01 (estimated)
NCT01308437	Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics	Phase 3	Terminated	2011-03	2013-04 (actual)
NCT05640531	Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771	Phase 1	Completed	Dec 1, 2011	Feb 7, 2012 (actual)
NCT04874324	Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349	Phase 1	Completed	Mar 17, 2011	May 4, 2011 (actual)
NCT03405064	Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)	Phase 3	Completed	Aug 25, 2017	Sep 25, 2018 (actual)
NCT02903836	Phase II Study of Oral Nafithromycin in CABP	II	Completed	Nov 18, 2016	2017-07 (actual)
NCT01352663	Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients	Phase 3	Withdrawn	Not listed	Not listed
NCT03981887	Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin	Phase 1	Completed	Jun 18, 2019	Jul 2, 2019 (actual)
NCT03979859	Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers	Phase 1	Completed	Aug 20, 2013	Dec 5, 2013 (actual)
NCT03926962	The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers	Phase 1	Completed	Mar 14, 2013	Jun 25, 2013 (actual)
NCT03630094	Plasma and Intrapulmonary Concentrations Study of WCK 5222	Phase 1	Completed	Mar 31, 2017	Jun 30, 2017 (actual)
NCT03622008	To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)	Phase 1	Completed	Mar 23, 2018	May 13, 2018 (actual)
NCT02942810	To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment	Phase 1	Completed	Oct 25, 2016	2017-04 (actual)
NCT02770404	A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects	1	Completed	Apr 25, 2016	Oct 25, 2016 (actual)
NCT03554304	Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers	Phase 1	Completed	Feb 9, 2017	Jun 5, 2017 (actual)
NCT02709382	A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment	Phase 1	Completed	2016-03	2016-08 (actual)
NCT02707107	MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers	Phase 1	Completed	2016-03	2016-04 (actual)
NCT02532140	Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime	Phase 1	Completed	2015-08	2015-11 (actual)
NCT02244827	Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment	Phase 1	Completed	2014-09	2014-12 (actual)
NCT02217930	Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers	Phase 1	Completed	2014-08	2014-12 (actual)
NCT02253342	Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects	Phase 1	Completed	2014-09	2014-12 (actual)
NCT02453529	Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects	Phase 1	Completed	2015-04	2015-07 (actual)
NCT01875939	Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers	I	Completed	2013-06	2013-06 (actual)
NCT01398670	Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics	Phase 3	Withdrawn	2012-02	2013-03 (estimated)
NCT01357603	Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM	Phase 1	Completed	2011-06	2012-05 (actual)
NCT01400789	Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects	Phase 1	Withdrawn	Not listed	Not listed
NCT01399255	Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects	Phase 1	Withdrawn	2011-11	2012-05 (estimated)
NCT01400802	Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects	Phase 1	Withdrawn	2011-11	2012-05 (estimated)
NCT00772265	Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects	Phase 1	Completed	2010-09	2011-03 (actual)
NCT00719108	Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.	Phase 1	Completed	2008-07	2008-09 (actual)
NCT01358435	Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects	Phase 1	Completed	2011-01	2011-05 (actual)
NCT00596063	Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.	Phase 1	Completed	2008-01	2008-02 (actual)
NCT00752180	Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics	Phase 1	Completed	2008-08	2009-03 (actual)

FDA records (last 2 years)

May 29, 2026 FDA New drug/biologic (novel): ZAYNICH (cefepime hydrochloride; zidebactam) — NDA220787, May 29, 2026. Applicant at approval: Wockhardt BIO AG. source ↗