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Hydrocodone Bitartrate

FDA-approved product (capsule, extended release, oral), marketed as Hydrocodone Bitartrate, Hysingla Er, Vantrela Er and 1 more.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

Chemical structure of Hydrocodone Bitartrate
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cough
  • Drug dependence
  • Pain

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Natural opium alkaloids; Opium alkaloids and derivatives
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA and K. pneumoniae. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA44.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli36.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae46.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis36.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-6.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.0 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-6.9 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.2 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Hydrocodone Bitartrate with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • NSAIDS Versus Opioids in Acute SER II Ankle Fractures

    NCT02373254 · start 2015-01

    Registered record
    Registry ID
    NCT02373254
    Conditions
    Ankle Fracture
    Interventions
    Ibuprofen; Acetaminophen/hydrocodone
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2015-01
    Completion
    2015-10
    Enrolment
    1

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAnkle Fracture
    InterventionIbuprofen; Acetaminophen/hydrocodone
    PhaseEarly phase 1
    Registry statusCompleted
  • A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain

    NCT02381132 · start 2014-11

    Registered record
    Registry ID
    NCT02381132
    Conditions
    Post Operative Pain
    Interventions
    Norco 7.5mg/325; MNK155
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2014-11
    Completion
    2015-12
    Enrolment
    99

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPost Operative Pain
    InterventionNorco 7.5mg/325; MNK155
    PhasePhase 3
    Registry statusTerminated
  • Peripheral Nerve Blocks in Pediatric Orthopedic Patients

    NCT02236130 · start 2014-06

    Registered record
    Registry ID
    NCT02236130
    Conditions
    Pediatric Extremity Fracture; Pediatric Extremity Soft Tissue Injury
    Interventions
    Regional block; General Anesthesia; Local Anesthetic Ropivacaine; Opioids Morphine; Oral pain medication Acetaminophen with Hydrocodone
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Terminated
    Start
    2014-06
    Completion
    2015-10
    Enrolment
    49

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPediatric Extremity Fracture; Pediatric Extremity Soft Tissue Injury
    InterventionRegional block; General Anesthesia; Local Anesthetic Ropivacaine; Opioids Morphine +1 more
    PhaseNot applicable
    Registry statusTerminated
  • Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

    NCT01780428 · start 2013-01

    Registered record
    Registry ID
    NCT01780428
    Conditions
    Pain; Nausea; Vomiting
    Interventions
    CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-01
    Completion
    2014-12
    Enrolment
    460

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPain; Nausea; Vomiting
    InterventionCL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg); Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet

    NCT01758978 · start 2012-12

    Registered record
    Registry ID
    NCT01758978
    Conditions
    Pain
    Interventions
    a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-12
    Completion
    2013-01
    Enrolment
    54

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPain
    Interventiona 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).
    PhasePhase 1
    Registry statusCompleted
  • Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery

    NCT01592708 · start 2012-06

    Registered record
    Registry ID
    NCT01592708
    Conditions
    Post-operative Nausea; Post-operative Vomiting; Nausea Persistent
    Interventions
    Antiemetic anesthesia protocol
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2012-06
    Completion
    2014-04
    Enrolment
    233

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPost-operative Nausea; Post-operative Vomiting; Nausea Persistent
    InterventionAntiemetic anesthesia protocol
    PhaseNot applicable
    Registry statusCompleted
  • Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

    NCT01402375 · start 2012-01

    Registered record
    Registry ID
    NCT01402375
    Conditions
    Analgesia After ED Discharge for Extremity Injuries
    Interventions
    Hydrocodone (first trial); Codeine (first trial); Oxycodone (for second trial); Codeine (for second trial); Oxycodone (third trial); Hydrocodone (third trial)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-01
    Completion
    2014-11
    Enrolment
    720

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAnalgesia After ED Discharge for Extremity Injuries
    InterventionHydrocodone (first trial); Codeine (first trial); Oxycodone (for second trial); Codeine (for second trial) +2 more
    PhasePhase 3
    Registry statusCompleted
  • Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco

    NCT01456520 · start 2011-10

    Registered record
    Registry ID
    NCT01456520
    Conditions
    Healthy
    Interventions
    Vycavert; Norco
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-10
    Completion
    2012-01
    Enrolment
    47

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionVycavert; Norco
    PhasePhase 1
    Registry statusCompleted
  • Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.

    NCT01400139 · start 2011-07

    Registered record
    Registry ID
    NCT01400139
    Conditions
    Chronic Nonmalignant and Nonneuropathic Pain
    Interventions
    Hydrocodone bitartrate q24h film-coated tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2011-07
    Completion
    2013-10
    Enrolment
    922

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionChronic Nonmalignant and Nonneuropathic Pain
    InterventionHydrocodone bitartrate q24h film-coated tablets
    PhasePhase 3
    Registry statusCompleted
  • A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

    NCT01319279 · start 2011-04

    Registered record
    Registry ID
    NCT01319279
    Conditions
    Hepatic Impairment
    Interventions
    Hydrocodone bitartrate extended-release tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-04
    Completion
    2011-08
    Enrolment
    16

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHepatic Impairment
    InterventionHydrocodone bitartrate extended-release tablet
    PhasePhase 1
    Registry statusCompleted
  • Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment

    NCT02242734 · start 2011-02

    Registered record
    Registry ID
    NCT02242734
    Conditions
    Hepatic Impairment
    Interventions
    20 mg HC-ER; 20 mg HC-ER; 20 mg HC-ER
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-02
    Completion
    2011-05
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHepatic Impairment
    Intervention20 mg HC-ER; 20 mg HC-ER; 20 mg HC-ER
    PhasePhase 1
    Registry statusCompleted
  • Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

    NCT01081912 · start 2010-03

    Registered record
    Registry ID
    NCT01081912
    Conditions
    Back Pain Lower Back Chronic
    Interventions
    Placebo; Hydrocodone bitartrate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2010-03
    Completion
    2011-10
    Enrolment
    510

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBack Pain Lower Back Chronic
    InterventionPlacebo; Hydrocodone bitartrate
    PhasePhase 3
    Registry statusCompleted
  • Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

    NCT01038609 · start 2009-12

    Registered record
    Registry ID
    NCT01038609
    Conditions
    Pain
    Interventions
    Hydrocodone/Acetaminophen Extended Release; Acetaminophen; Morphine Extended Release; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-12
    Completion
    2010-05
    Enrolment
    250

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPain
    InterventionHydrocodone/Acetaminophen Extended Release; Acetaminophen; Morphine Extended Release; Placebo
    PhasePhase 2
    Registry statusCompleted
  • A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)

    NCT02126917 · start 2009-11

    Registered record
    Registry ID
    NCT02126917
    Conditions
    Healthy
    Interventions
    HC-ER + 40% Alcohol; HC-ER + 20% Alcohol; HC-ER + 0% Alcohol
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2009-11
    Completion
    2009-12
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionHC-ER + 40% Alcohol; HC-ER + 20% Alcohol; HC-ER + 0% Alcohol
    PhasePhase 1
    Registry statusCompleted
  • The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache

    NCT00574015 · start 2007-12

    Registered record
    Registry ID
    NCT00574015
    Conditions
    Toothache
    Interventions
    hydrocodone/acetaminophen; bupivacaine (supraperiosteal nerve block)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2007-12
    Completion
    2013-01
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionToothache
    Interventionhydrocodone/acetaminophen; bupivacaine (supraperiosteal nerve block)
    PhasePhase 4
    Registry statusCompleted