Codeine Sulfate

(Codeine)

PreclinicalSmall molecule

HHikma Pharmaceuticals LLC

Codeine Sulfate is one of 5 small molecule programs targeting Analgesic. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AnalgesicTerminated

AnalgesicPreclinical

Terminated

Competition

Competitive Landscape

5 competitors in Analgesic

#DrugCompanyPhaseTrials

Dynastat

Pfizer

Phase 3

1 2

Acupan

YYonsei University

Phase 2

2 3

Dexketoprofen Trometamol

Menarini

Preclinical

1 4

Codeine Sulfate

HHikma Pharmaceuticals LLC

Preclinical

1 5

Tropisetron

UUniversity Hospital, Clermont-Ferrand

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

TIA1 trial

Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

Completed· Pfizer logo

Pfizer·Phase 1·NCT00456898·40 enrolled

Post Operative Pain1 trial

Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain

Completed·UUniversity of Sao Paulo General Hospital·Phase 3·NCT02625753·40 enrolled

Sickle Cell Disease1 trial

Codeine in Sickle Cell Disease

Completed·PPriCara, Unit of Ortho-McNeil, Inc.·Phase 1/2·NCT00174538·60 enrolled

Tics1 trial

Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 1·NCT01845194·117 enrolled

Analgesic1 trial

Opioid Analgesics for Acute Fracture Pain in Adults Discharged From the ED

Terminated·MMount Sinai Hospital, Canada·N/A·NCT03478423·5 enrolled

10 more indications

Drug Metabolism1 trial

Open Label Study for the Functional Characterization of Drug Metabolism and Transport

Completed·MMatthias Schwab·Phase 1·NCT01788254·144 enrolled

Craniotomy1 trial

Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

Completed·TTan Tock Seng Hospital·Phase 4·NCT01672112·40 enrolled

Abdominal Surgery1 trial

Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.

Completed·—·Phase 3·NCT04641338·491 enrolled

Opioid Analgesia1 trial

Assessment of Opioid Analgesia in Sickle Cell

Withdrawn·—·Phase 4·NCT00513864

Pregnancy1 trial

A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.

Completed·SSt. Louis University·N/A·NCT02295280·70 enrolled

Gastric1 trial

Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects

Completed·MMichael Camilleri·Phase 1·NCT02737059·72 enrolled

Pediatric Patients1 trial

A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain

Terminated·RRoxane Laboratories·Phase 3·NCT01676493·31 enrolled

TED1 trial

Codeine in Mechanically Ventilated Neonates

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1·NCT01322204·6 enrolled

Pain Management1 trial

Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge

Completed·MMontefiore Medical Center·Phase 3·NCT01402375·720 enrolled

Unspecified1 trial

CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS

Completed·PPontificia Universidad Catolica de Chile·Phase 4·NCT06907355·196 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 16, 2009

CODEINE SULFATE

NDA NDA022402

Jun 30, 2011

CODEINE SULFATE

NDA NDA202245

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Codeine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Codeine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Codeine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202245). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: HHikma Pharmaceuticals LLC

Codeine Sulfate

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

TIA1 trial

Post Operative Pain1 trial

Sickle Cell Disease1 trial

Tics1 trial

Analgesic1 trial

Drug Metabolism1 trial

Craniotomy1 trial

Abdominal Surgery1 trial

Opioid Analgesia1 trial

Pregnancy1 trial

Gastric1 trial

Pediatric Patients1 trial

TED1 trial

Pain Management1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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