Last update 24 Jun 2024
Emtricitabine
Last update 24 Jun 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms (2R-cis)-4-amino-5-fluoro-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone, (−)-(2R,5S)-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine, (−)-2'-deoxy-5-fluoro-3'-thiacytidine + [18] |
Target |
Mechanism RT inhibitors(Reverse transcriptase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (02 Jul 2003), |
RegulationOrphan Drug (JP) |
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Structure
Molecular FormulaC8H10FN3O3S |
InChIKeyXQSPYNMVSIKCOC-NTSWFWBYSA-N |
CAS Registry143491-57-0 |
Related
121
Clinical Trials associated with EmtricitabineReverse Transcriptase Inhibitors in Aicardi Goutières Syndrome
Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses
Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation
100 Clinical Results associated with Emtricitabine
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100 Translational Medicine associated with Emtricitabine
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100 Patents (Medical) associated with Emtricitabine
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3,960
Literatures (Medical) associated with Emtricitabine01 Mar 2024Current drug research reviews
Development and Validation of RP-HPLC Method for the Estimation of
Tenofovir and Emtricitabine in Bulk and Pharmaceutical Dosage Form
Article
Author: Rao, Pallepogu Venkateswara ; Sahoo, Biswa Mohan ; Rao, Naidu Srinivasa
Background::
A novel, simple, efficient, rapid, and precise reverse-phase highperformance
liquid chromatography (RP-HPLC) method was developed for the estimation of
Tenofovir and Emtricitabine in the bulk and pharmaceutical dosage form. The currently developed
method was subsequently validated according to ICH guidelines in terms of linearity, accuracy,
precision, the limit of detection, the limit of quantification, robustness, etc.
Methods::
The separation of the selected drugs was optimized after several trials including change
of mobile phase and its composition, stationary phase, flow rate, column temperature, etc. The
separation was performed by using an Inertsil ODS C18 column (250 mm x 4.6 mm, 5μ) and UV
absorption was measured at 231 nm. Methanol: Acetonitrile: Water was selected as the mobile
phase in the ratio of 50:20:30 (V/V/V) at a flow rate of 1 mL/min. As per International Conference
on Harmonization (ICH) Q2 R1 guidelines, several validation parameters were evaluated
which include specificity, linearity, precision, accuracy, the limit of detection (LOD), and the limit
of quantitation (LOQ).
Results::
The acceptable degree of linearity range was found to be 40-100 μg/mL. The standard solution
exhibited retention times of 3.06 minutes and 5.07 minutes for Tenofovir and Emtricitabine respectively.
The LOD and LOQ obtained were 0.05 μg/ml and 0.02 μg/mL, 15 μg/mL, and 0.08 μg/mL for
Tenofovir and Emtricitabine respectively. The percent recovery was found to be 98 to 102%.
Conclusion::
Hence, the proposed method is simple, selective, and specifically meets the requirements
of ICH guidelines for the validation of the analytical method.
01 Mar 2024Journal of pharmaceutical and biomedical analysis
Development and validation of an ultra-high performance liquid chromatography-tandem mass spectrometry method to quantify antiretroviral drug concentrations in human plasma for therapeutic monitoring
Article
Author: Devanathan, Aaron S ; Riddler, Sharon A ; Nolin, Thomas D ; Oberly, Patrick J ; West, Raymond E
Antiretroviral therapy (ART) is highly effective for the treatment of HIV-1 infection. ART previously consisted of concomitant administration of many drugs, multiple times per day. Currently, ART generally consists of two- or three-drug regimens once daily as fixed-dose combinations. Drug monitoring may be necessary to ensure adequate concentrations are achieved in the plasma over the dosing interval and prevent further HIV resistance formation. Additionally, nonadherence remains an issue, highlighting the need to ensure sufficient ART exposure. Towards this effort, we developed and validated a highly selective ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of a panel of nine antiretrovirals: abacavir, bictegravir, cabotegravir, dolutegravir, doravirine, emtricitabine, lamivudine, raltegravir, and tenofovir in human plasma. Using only 50 µL of plasma, a simple protein precipitation with acetonitrile with internal standards followed by reconstitution in 50 uL (high) or 400 uL (low) was performed. Analyte separation was achieved using a multistep UPLC gradient mixture of (A: 0.1% formic acid in water and B: acetonitrile) and a Waters CORTECS T3 (2.1 ×100 mm) column. The method was comprehensively validated according to the United States Food and Drug Administration Bioanalytical Guidelines over two clinically relevant ranges (1-250 ng/mL and 100-5000 ng/mL) with excellent linearity (R2 > 0.99 for all). The assay run time was 7.5 min. This method achieves acceptable performance of trueness (89.7-104.1%), repeatability, and precision (CV <15%), and allows for simultaneous quantification of guideline-recommended ART regimens. This method can be utilized for the therapeutic monitoring of antiretrovirals in human plasma.
01 Feb 2024Infection
Natural course of AIDS following HIV-2 infection
Article
Author: Fuhr, Hannah ; Christopeit, Maximilian
Abstract:
In a 21-year-old female, AIDS following infection with HIV-2 was diagnosed alongside an HIV-associated high-grade B cell lymphoma. Treatment of HIV-2 with dolutegravir, emtricitabine, and tenofovir resulted in viral suppression and slow recovery of CD4 cell counts. Treatment of lymphoma caused significant adverse effects but led to complete remission. The patient denied sexual activity and intravenous drug abuse. The patient had been born to an HIV-2-positive mother but appropriate perinatal testing based on national guidelines had remained negative. This case recapitulates the natural course of HIV-2 infection.
88
News (Medical) associated with Emtricitabine30 May 2024
Drug ApprovalLicense out/inClinical Study
15 May 2024
13 May 2024
Gene TherapyPhase 1Clinical ResultsiRNA
100 Deals associated with Emtricitabine
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01199 | Emtricitabine |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HIV Infections | US | 02 Jul 2003 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hepatitis B, Chronic | Phase 2 | US | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | AU | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | CA | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | FR | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | DE | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | HK | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | NZ | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | PL | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | SG | 01 Sep 2007 | |
| Hepatitis B, Chronic | Phase 2 | TW | 01 Sep 2007 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 1 | 10 | qtmndgbdpp(gvlxjdezjm) = dncipoohnu pnesdvanke (shmpkslwtk, gnqoiqyttl - mjstqunyvl) View more | - | 12 Apr 2023 | |||
Phase 3 | 452 | (Study 1489) | abbuwypwzb(imszuyeyjv) = jpcwawpyay xiuuimqldm (dmeronzjnf ) | Positive | 24 Oct 2022 | ||
(Study 1490) | abbuwypwzb(imszuyeyjv) = cfkoslisxu xiuuimqldm (dmeronzjnf ) | ||||||
Not Applicable | Maintenance | 187 | Dolutegravir plus Emtricitabine | fzgqeamyky(rpxcyibvyh) = ckfqnasnnr xavdvnzwtb (vxgzufwmyj ) View more | Positive | 01 Jan 2022 | |
Combined Antiretroviral Therapy | fzgqeamyky(rpxcyibvyh) = hicylacqnf xavdvnzwtb (vxgzufwmyj ) View more | ||||||
NCT02881320 (Pubmed) Manual  | Phase 2/3 | HIV Infections First line | 100 | bictegravir+emtricitabine+tenofovir alafenamide | nniwjzzrdw(ziiofdxowl) = hbuffeuhjr ltwimwmtce (lchrzksrpn ) View more | Positive | 01 Sep 2021 |
NCT04685512 (Pubmed) Manual | Phase 2 | 60 | ppnksdnykn(wqcgfmzcdw): difference = 2.3 (95% CI, -0.6 to 5.2), P-Value = 0.13 View more | Positive | 01 Aug 2021 | ||
standard of care | |||||||
Phase 3 | 5,387 | kqshrgabpy(upzotsozpd) = oozfqgohxb zxthhfpmio (qrozaaihgf, 0.07 - 0.31) View more | Non-inferior | 01 Jul 2021 | |||
kqshrgabpy(upzotsozpd) = wsmaqoayol zxthhfpmio (qrozaaihgf, 0.17 - 0.49) View more | |||||||
Phase 4 | 48 | estradiol (Transgender Women) | svraaiaety(qzylewzumb) = wygubyxddm rctdezxpcr (myprrdptmu, cwwkrkltuc - smmxnbmxnf) View more | - | 11 May 2021 | ||
testosterone (Transgender Men) | svraaiaety(qzylewzumb) = auhnhyqyhx rctdezxpcr (myprrdptmu, jeopdafirk - qsnobxbqkh) View more | ||||||
Phase 3 | HIV Infections M184V Mutation | M184I Mutation | 64 | cquygnhbuv(wzzlcllrma) = kfryfiggew sfuylcnraz (qxyzciquld ) View more | Positive | 01 Apr 2021 | ||
Not Applicable | - | 43 | wolfljxkha(hxbxutigjl) = gyurzueqza mvgisxggms (jcflurxfgw ) | - | 01 Jan 2021 | ||
Not Applicable | - | 86 | smxwklikhe(fwlreqoreq) = Median CD4 counts were stable vuorkgquxj (ppsurfmycw ) | - | 01 Jan 2021 |
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