MedPath

Durect

Ownership
-
Employees
58
Market Cap
-
Website
Introduction

DURECT Corp. focuses on advancing novel and potentially lifesaving investigational therapies derived from its Epigenetic Regulator Program. Its pipeline is called DUR-928, an endogenous sulfated oxysterol and an epigenetic regulator. The company was founded by James E. Brown and Felix Theeuwes on February 6, 1998 and is headquartered in Cupertino, CA.

A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

Phase 2
Completed
Conditions
Alcoholic Hepatitis
Interventions
Drug: DUR-928 30 mg
Drug: Placebo+ Standard of Care (SOC)
Drug: DUR-928 90 mg
First Posted Date
2020-09-24
Last Posted Date
2024-02-26
Lead Sponsor
Durect
Target Recruit Count
307
Registration Number
NCT04563026
Locations
🇺🇸

Stanford University Medical Center, Stanford, California, United States

🇺🇸

Mount Sinai Hospital, New York, New York, United States

🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

and more 65 locations

DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

Phase 2
Terminated
Conditions
SARS-CoV-2
Interventions
Drug: Placebo
First Posted Date
2020-06-25
Last Posted Date
2022-08-05
Lead Sponsor
Durect
Target Recruit Count
2
Registration Number
NCT04447404
Locations
🇺🇸

Site 03, Newark, New Jersey, United States

Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

Phase 2
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: DUR-928 Topical Solution
Drug: Vehicle Topical Solution
First Posted Date
2019-02-12
Last Posted Date
2022-09-02
Lead Sponsor
Durect
Target Recruit Count
25
Registration Number
NCT03837743
Locations
🇺🇸

Site 05, Tampa, Florida, United States

🇺🇸

Site 02, Plainfield, Indiana, United States

🇺🇸

Site 03, Spokane, Washington, United States

and more 2 locations

A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Phase 2
Completed
Conditions
Alcoholic Hepatitis
Interventions
Drug: DUR-928 90 mg
Drug: DUR-928 150 mg
Drug: DUR-928 30 mg
First Posted Date
2018-02-14
Last Posted Date
2022-12-14
Lead Sponsor
Durect
Target Recruit Count
19
Registration Number
NCT03432260
Locations
🇺🇸

DURECT Study Site 0004, Atlanta, Georgia, United States

🇺🇸

DURECT Study Site 0002, Chicago, Illinois, United States

🇺🇸

DURECT Study Site 0005, Louisville, Kentucky, United States

and more 4 locations

A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

Phase 2
Terminated
Conditions
Primary Sclerosing Cholangitis
Interventions
First Posted Date
2018-01-09
Last Posted Date
2022-10-17
Lead Sponsor
Durect
Target Recruit Count
5
Registration Number
NCT03394781
Locations
🇺🇸

Charlotte Mecklenburg Hospital, Charlotte, North Carolina, United States

🇺🇸

California Pacific Medical Center, San Francisco, California, United States

🇺🇸

Southern Therapy and Advanced Research, Jackson, Mississippi, United States

and more 1 locations

Trial of Extended Release Bupivacaine for Pain Relief After Surgery

Phase 3
Completed
Conditions
Post Operative Pain
Interventions
Drug: SABER-Bupivacaine (Part 1)
Drug: SABER-Bupivacaine (Part 2)
Drug: Saline Placebo
First Posted Date
2015-10-14
Last Posted Date
2021-07-13
Lead Sponsor
Durect
Target Recruit Count
399
Registration Number
NCT02574520
Locations
🇺🇸

Durect Study Site 04, Florence, Alabama, United States

🇺🇸

Durect Study Site 03, Sheffield, Alabama, United States

🇺🇸

Durect Study Site 15, Fontana, California, United States

and more 18 locations

An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

Completed
Conditions
Pain
First Posted Date
2010-06-09
Last Posted Date
2022-06-15
Lead Sponsor
Durect
Target Recruit Count
47
Registration Number
NCT01139866

Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

Phase 2
Completed
Conditions
Chronic Low Back Pain
Interventions
First Posted Date
2010-03-31
Last Posted Date
2022-06-15
Lead Sponsor
Durect
Target Recruit Count
263
Registration Number
NCT01096966

Bupivacaine Effectiveness and Safety in SABER® Trial

Phase 3
Completed
Conditions
Postoperative Pain
Abdominal Surgery
Interventions
Drug: SABER-Bupivacaine
Drug: SABER-Placebo
First Posted Date
2010-01-20
Last Posted Date
2021-06-01
Lead Sponsor
Durect
Target Recruit Count
331
Registration Number
NCT01052012
Locations
🇳🇿

DURECT Study Site, Christchurch, New Zealand

An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

Phase 2
Completed
Conditions
Postoperative Pain
Interventions
Drug: SABER-Bupivacaine Treatment 2a
Drug: Placebo SABER-Bupivacaine Treatment 2b
Drug: SABER-Bupivacaine Treatment 1a
Drug: Placebo SABER-Bupivacaine Treatment 1b
First Posted Date
2009-10-12
Last Posted Date
2021-06-01
Lead Sponsor
Durect
Target Recruit Count
115
Registration Number
NCT00993226
Locations
🇬🇧

Nycomed, London, United Kingdom

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