Dexibuprofen

Overview

Dexibuprofen, S(+)-ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID). It is a pharmacologically effective enantiomer of racemic ibuprofen that differs in physicochemical properties. It is proposed to be more pharmacologically active and tolerable with a better safety profile than ibuprofen due to higher concentration of active S enantiomer. Dexibuprofen has a slower dissolution rate in the simulated gastric and enteric juices compared with the racemic ibuprofen and displays improved oral bioavilability . For Metabolism, Enzymes, Carriers, Transporters Sections, refer to Ibuprofen.

Indication

For more information, refer to ibuprofen.

Associated Conditions

Fever
Inflammation
Pain
Spasms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions	2016/11/06	NCT02956512	Phase 1	Completed	Apsen Farmaceutica S.A.
Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions	2016/11/06	NCT02956525	Phase 1	Completed	Apsen Farmaceutica S.A.
Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee	2010/02/10	NCT01066676	Phase 4	Completed	Gebro Pharma GmbH
The Efficacy and Safety of Dexibuprofen Syrup	2008/12/22	NCT00812422	Phase 3	Completed	Inje University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DEXIBUPROFENO STRIDES 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Strides Pharma (Cyprus) Limited	85359	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
DEXIBUPROFENO STRIDES 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Strides Pharma (Cyprus) Limited	85360	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
SERACTIL 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Laboratorios Gebro Pharma S.A.	63574	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ATRISCAL 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Laboratorios Gebro Pharma S.A.	63607	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ATRISCAL 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Laboratorios Gebro Pharma S.A.	63606	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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