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Last update 28 Apr 2026

Emtricitabine

Last update 28 Apr 2026

Overview

R&D Status

Clinical Result

Translational Medicine

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

Action

inhibitors

Mechanism

RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication

Aicardi-Goutieres SyndromeCoinfectionHepatitis B+ [5]

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences Ireland UC

Gilead Sciences, Inc.

Hebei Medical University Pharmaceutical Factory

Inactive Organization

Triangle Pharmaceuticals, Inc.

License Organization

Gilead Sciences, Inc.

Triangle Pharmaceuticals, Inc.

Royalty Pharma AG

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (02 Jul 2003),

HIV Infections

RegulationOrphan Drug (Japan)

Structure/Sequence

Molecular FormulaC8H10FN3O3S

InChIKeyXQSPYNMVSIKCOC-NTSWFWBYSA-N

CAS Registry143491-57-0

161

Clinical Trials associated with Emtricitabine

NCT03304717

/ WithdrawnPhase 1/2

Reverse Transcriptase Inhibitors in Aicardi Goutières Syndrome

The overall objectives are to explore the safety and efficacy of Reverse Transcriptase Inhibitors Tenofovir (TDF)/ Emtricitabine (FTC) administered in AGS affected children 2 to 18 years of age.

Start Date01 Dec 2025

Sponsor / Collaborator

The Children's Hospital of Philadelphia

[+5]

NCT07062614

/ RecruitingNot ApplicableIIT

Exploration of Intra-individual Variability of Exposure to Emtricitabine and Lamivudine in Hair With a View to Validating the Value of This Matrix as a Diagnostic Tool for Partial and/or Total Non-compliance With Antiretroviral Treatment

Treatment adherence is defined by compliance with the dosage schedule (i.e., dose per dose and number of doses per day), as well as the duration of administration (i.e., number of days during which the dosage schedule must be followed).
Treatment adherence determines the therapeutic efficacy and the absence of toxicity of the prescribed medication. However, this adherence is far from being respected even by patients with serious pathologies such as patients living with HIV (PLWHIV). However, among PLWHIV, non-adherence is a significant source of virological failure and is difficult to assess because it is most often based on what the patient reports to their doctor. A currently used approach consists of determining the drug concentration in the blood and possibly that of its metabolite(s). However, determining a drug's blood concentration presents two major pitfalls: (i) it is necessary to take a blood sample, which remains an invasive procedure for the patient; (ii) for the vast majority of drugs, if the patient scrupulously adheres to the dosage schedule a few days before the blood sample is taken, the drug concentration is most often within the expected range. Therefore, a concentration in the reference range does not exclude partial or even total non-compliance between two medical visits. Saliva is a more easily accessible matrix than blood. However, the same representativeness problem is encountered due to the fact that saliva is in almost instantaneous equilibrium with blood.
Urine could be used to assess compliance. However, this requires multiple urine collections between two doses. This constraint is not compatible with the organization of clinical services. The objective is to determine intra-individual variability in the amount of antiretroviral (ARV) in different segments of the same strand of hair during periods of full treatment adherence.
This objective is preliminary to the use of hair as a tool for detecting treatment non-adherence in patients.
Two reference antiretroviral molecules will be documented: Emtricitabine and Lamivudine, as they are present, one or the other, in the majority of antiretroviral combination strategies.

Start Date03 Jul 2025

Sponsor / Collaborator

Toulouse University Hospital

NCT07210528

/ RecruitingPhase 1IIT

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Emtricitabine and Descovy in Patients With Mild Cognitive Impairment.

Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD.
This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets.
This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention.
This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers.
Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period.
The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.

Start Date30 Jun 2025

Sponsor / Collaborator

National University Hospital

100 Clinical Results associated with Emtricitabine

100 Translational Medicine associated with Emtricitabine

100 Patents (Medical) associated with Emtricitabine

5,491

Literatures (Medical) associated with Emtricitabine

01 Mar 2026·HISTOLOGY AND HISTOPATHOLOGY

USP7 promotes follicular thyroid carcinoma progression and sorafenib resistance by activating NEK2/ATG5-mediated autophagy.

Article

Author: Luo, Jie ; Deng, Yingcheng ; Zeng, Jutao ; Cao, Hong

PURPOSE:

To investigate the role of ubiquitin-specific protease 7 (USP7) in thyroid cancer (TC) pathogenesis and sorafenib resistance.

METHODS:

USP7 expression was compared in normal human thyroid cells and TC cells. The TC line with maximal differential USP7 expression was selected for further study. The functional interaction between USP7 and never in mitosis A (NIMA)-related kinase 2 (NEK2)/autophagy-related 5 (ATG5) was elucidated through a Pearson correlation coefficient analysis and co-immunoprecipitation assay. The half-inhibitory concentration (IC50) of sorafenib in resistant follicular thyroid (FTC) cells was determined following USP7 knockdown and ATG5 overexpression. Furthermore, the effects of USP7 knockdown and the autophagy inducer rapamycin (RAPA) on FTC cell function were assessed by colony formation and Transwell assays. The function of USP7 was validated in vivo using a xenograft mouse model, and tumor growth was assessed through gross examination and histopathological staining.

RESULTS:

High USP7 expression promoted the proliferation, migration, and invasion of FTC cells and was positively correlated with NEK2 and ATG5 levels. USP7 enhanced NEK2 stability via deubiquitination. Knocking down USP7 downregulated ATG5, and this effect was reversed by NEK2 overexpression. USP7 inhibition reduced the IC₅₀ of sorafenib in FTC cells, which was reversed by ATG5 overexpression. USP7 knockdown attenuated FTC cell proliferation, migration, and invasion while increasing the apoptosis rate, and these effects were reversed by RAPA treatment. Knocking down USP7 suppressed the growth of TC xenografts in vivo, improved tumor tissue differentiation, and reduced the percentage of Ki-67-positive cells.

CONCLUSION:

USP7 promoted the progression of FTC and induced sorafenib resistance by enhancing NEK2/ATG5-mediated autophagy. This study provides novel insights and potential therapeutic strategies for FTC treatment and overcoming drug resistance.

01 Mar 2026·Health Science Reports

Inflammatory Biomarkers Decay After First‐Line Antiretroviral Therapy Initiation With Dolutegravir/Lamivudine or Bictegravir/Emtricitabine/Tenofovir Alafenamide in Persons With HIV: A Substudy of a Randomized Clinical Trial

Article

Author: Raul Rigo Bonin ; Sofía Scevola ; Maria Saumoy ; Daniel Podzamczer ; Juan Tiraboschi ; Analuz Fernandez ; Arkaitz Imaz

01 Mar 2026·INTERNATIONAL JOURNAL OF STD & AIDS

High-level multi-class transmitted antiretroviral resistance in a man with newly acquired HIV

Article

Author: Miller, Theodore R. ; Sison, Raymund ; Gruta, Cristina ; Fierer, Daniel S.

A 19 year old man was diagnosed newly acquired HIV and prescribed bictegravir/emtricitabine/tenofovir alafenamide at his initial visit for HIV care. The genotype results from that initial visit returned two weeks later, showing high-level multi-class transmitted drug resistance, including multiple resistance-associated mutations (RAM) in the integrase gene. Although he had an initial substantial decline in viremia in the first 4 weeks, it was felt that the risk of subsequent failure was too high, and his antiretroviral treatment (ART) regimen was therefore changed to daily dolutegravir and darunavir/cobicistat/emtricitabine/tenofovir alafenamide, plus injected lenacapavir. He had durable virologic suppression on this new regimen for 12 months as of his last follow-up. This case of high-level multi-class transmitted drug resistance, in the context of rapid emergence of resistance to dolutegravir where it has been used as part of a salvage regimen, suggests that assessing for RAM in the integrase gene should be added to the currently recommended resistance testing for all patients with newly acquired HIV prior to initiating ART.

259

News (Medical) associated with Emtricitabine

22 Apr 2026

·allsci.com

FDA approves Merck’s Idvynso for HIV-1 treatment in virologically suppressed adults

The US FDA approved Idvynso (doravirine/islatravir) for Merck, marking the first non-integrase strand transfer inhibitor (INSTI), tenofovir-free, once-daily complete two-drug regimen to reach approval for HIV-1 treatment in adults. The fixed-dose combination of 100 mg doravirine and 0.25 mg islatravir is indicated as a switch regimen for virologically suppressed adults with no history of virologic treatment failure and no known resistance substitutions associated with doravirine. The approval covers use in adults with HIV-1 RNA below 50 copies per mL on a stable antiretroviral regimen for at least three months. Idvynso is a complete regimen; co-administration with other antiretrovirals is not recommended. The drug is contraindicated with strong CYP3A enzyme inducers and with lamivudine or emtricitabine, as co-administration may reduce islatravir-triphosphate concentrations and compromise efficacy. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with doravirine-containing regimens, and one case of Drug Rash with Eosinophilia and Systemic Symptoms was observed during clinical trials. The approval is supported by Week 48 data from two randomized, active-controlled, non-inferiority Phase III trials. Trial 052 (NCT05630755) was a double-blind study in 513 virologically suppressed adults previously receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), randomized 2:1 to switch to Idvynso or continue BIC/FTC/TAF. At Week 48, 1% of participants in each arm had HIV-1 RNA ≥50 copies/mL (treatment difference 0.9%, 95% CI: -1.9%, 2.9%), with 92% of Idvynso recipients maintaining viral suppression versus 94% on BIC/FTC/TAF. Trial 051 (NCT05631093) enrolled 551 participants switching from a range of antiretroviral regimens, including 64% on INSTI-based therapy. In this open-label study, 1% of Idvynso recipients versus 5% of those continuing baseline therapy had HIV-1 RNA ≥50 copies/mL at Week 48 (treatment difference -3.6%, 95% CI: -7.8%, -0.8%), with 96% versus 92% maintaining suppression. Safety profiles across both trials were comparable to comparator arms, with adverse events leading to discontinuation in 3% and 0.5% of Idvynso recipients in Trials 052 and 051, respectively. The approval adds a mechanistically distinct oral option to a treatment landscape that has been shaped predominantly by INSTI-based regimens. Gilead’s Biktarvy (BIC/FTC/TAF) and ViiV Healthcare’s Dovato (dolutegravir/lamivudine) have become the reference standards for virologically suppressed adults, while ViiV’s long-acting injectable Cabenuva (cabotegravir/rilpivirine) addresses the growing demand for less frequent dosing. Idvynso enters this field as the only approved oral two-drug regimen that avoids both INSTIs and tenofovir, a profile relevant to patients managing renal impairment, bone density concerns, or INSTI-associated metabolic effects including weight gain. Islatravir’s dual mechanism — translocation inhibition and delayed chain termination — distinguishes it from conventional NRTIs, and its activity at low doses underpins the two-drug strategy. The published Phase III data supporting the approval appeared in The Lancet HIV in 2024, including a head-to-head comparison against BIC/FTC/TAF by Mills et al. and a broader switch study by Molina et al. Islatravir’s broader role in Merck’s HIV pipeline extends beyond the approved daily formulation. The company is evaluating islatravir in combination with Gilead’s lenacapavir as a potential once-weekly oral regimen in the Phase III ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299) trials, and in combination with the investigational NNRTI ulonivirine (MK-8507) in Phase IIb development. A separate once-monthly oral PrEP candidate, MK-8527, has entered Phase III evaluation in collaboration with the Gates Foundation, targeting HIV acquisition in women and adolescent girls in sub-Saharan Africa. These programs reflect a broader industry shift toward reducing dosing frequency while preserving or improving the tolerability profile that has defined the modern ART era. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultDrug ApprovalPhase 2Accelerated Approval

22 Apr 2026

·www.pharmaceutical-technology.com

FDA approves MSD’s once-daily HIV combo Idvynso

Idvynso is the first non-INSTI, tenofovir-free, two-drug regimen to get the FDA’s blessing. Credit: Tatyana Frolova / Shutterstock.com. MSD (Merck & Co) has secured a US approval for its two-drug human immunodeficiency virus (HIV) combination therapy, Idvynso (doravirine/islatravir), as the company looks to secure a slice of the lucrative market. Once-daily Idvynso was given the US regulatory greenlight based on the results of the Phase III MK-8591A-051 and MK-8591A-052 (NCT05631093; NCT05630755) trials, which found that patients switched from Gilead’s SoC therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), maintained viral suppression at a non-inferior level when taking Idvynso daily. This means that American patients who are virologically suppressed and on a stable antiretroviral (ART) regimen can now be switched to Idvynso, provided they have not previously experienced virologic treatment failure or doravirine resistance. According to Anaelle Tannen, infectious disease analyst at GlobalData, Idvynso’s regulatory greenlight reflects a broader shift in the HIV treatment landscape away from traditional three-drug combinations toward simpler, potentially more tolerated options. Currently, the HIV market is dominated by Gilead’s three-drug regimen, Biktarvy, though GSK’s dual therapy, Dovato (dolutegravir/lamivudine), also holds a strong share. Unlike Biktarvy and Dovato, however, Idvynso does not contain an integrase strand transfer inhibitor (INSTI), which can be linked to tolerability issues. Because of its departure from reliance on INSTIs, Tannen says that Idvynso will likely see virologically suppressed patients switch, particularly those who need alternatives due to “tolerability or class-related issues”. However, Tannen does not foresee Idvynso displacing established first-line SoC therapies like Biktarvy, as they have better physician familiarity and established safety and efficacy in HIV. According to patient-based forecasts from GlobalData, parent company of Pharmaceutical Technology , Biktarvy’s sales will peak at $13.2bn in 2032, while Idvynso will pull in $1.6bn that same year. For Idvynso to differentiate itself in the long term, Tannen notes that the drug must demonstrate “clear advantages in weight neutrality or reduced metabolic impact”, which has been a side effect linked to INSTIs like dolutegravir and bictegravir. Idvynso’s combinatory potential While analysts do not predict that Idvynso will have a SoC-changing market impact as a monotherapy, MSD is taking another shot at glory on the HIV market through a late-stage combination programme, which will see the company gauge the potential of Idvynso plus Gilead’s HIV drug, Sunlenca (lenacapavir), as a once-weekly treatment option. The therapeutic duo has already shown promise in a Phase II trial , where it maintained viral suppression on a weekly dosing regimen for two years. If approved, Idvynso-Sunleca could become the first oral treatment option for HIV with this dosing pattern. A recent report from GlobalData projects the global HIV marketplace to experience modest growth during the forecast period, as the indication becomes increasingly competitive.

Phase 2Phase 3Clinical ResultDrug Approval

21 Apr 2026

·firstwordpharma.com

FDA clears Merck & Co.'s two-drug HIV pill Idvynso

The FDA on Tuesday approved Merck & Co.'s Idvynso, a once-daily single-tablet regimen combining doravirine and islatravir for adults with virologically suppressed HIV-1, expanding options for patients switching off existing antiretroviral (ARV) therapies. The clearance came a week ahead of its April 28 decision date.The drug is specifically indicated for patients with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine."As the only two-drug, non-INSTI [integrase strand transfer inhibitor], tenofovir-free regimen, Idvynso expands therapeutic diversity beyond the currently available oral treatment options," said Eliav Barr, chief medical officer at Merck Research Laboratories.Doravirine, a non-nucleoside reverse transcriptase inhibitor, is already approved as Pifeltro and as part of a fixed-dose tablet marketed as Delstrigo (doravirine/lamivudine/tenofovir), while islatravir belongs to a new ARV class known as nucleoside reverse transcriptase translocation inhibitors.Merck's filing was based on two Phase III trials that enrolled more than 1000 patients across switch settings.In the MK-8591A-052 study, 1% of patients switched to Idvynso had viral loads ≥50 copies/mL at week 48, compared with 1% of those who remained on Gilead Sciences' once-daily, single-tablet Biktarvy, which combines three drugs: bictegravir, emtricitabine and tenofovir alafenamide. Viral suppression rates, a secondary endpoint of the study, were 92% and 94%, respectively.The second study, known as MK-8591A-051, involved patients switching from a range of ARV regimens, and showed that 1% of those on Idvynso had a viral load of ≥50 copies/mL at week 48 versus 5% on baseline therapy, while 96% maintained suppression versus 92% in the control group.Last year, Merck reported results from a third Phase III trial dubbed MK-8591A-053 showing that its tablet was non-inferior to Biktarvy in treatment-naïve adults with HIV.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Emtricitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01199	Emtricitabine	J05AF09	DB00879

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	United States	Gilead Sciences, Inc.	02 Jul 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Aicardi-Goutieres Syndrome	Phase 2	-	Gilead Sciences, Inc.	01 Dec 2025
Hepatitis C	Phase 2	United States	Gilead Sciences, Inc.	01 Mar 2012
Hepatitis C, Chronic	Phase 2	United States	Gilead Sciences, Inc.	01 Mar 2012
Pregnancy	Phase 2	Cambodia	Gilead Sciences, Inc.	01 Oct 2006
Pregnancy	Phase 2	Côte d'Ivoire	Gilead Sciences, Inc.	01 Oct 2006
Pregnancy	Phase 2	South Africa	Gilead Sciences, Inc.	01 Oct 2006
Hepatitis B, Chronic	Phase 2	United States	Gilead Sciences, Inc.	01 Mar 2006
Hepatitis B, Chronic	Phase 2	France	Gilead Sciences, Inc.	01 Mar 2006
Hepatitis B, Chronic	Phase 2	Germany	Gilead Sciences, Inc.	01 Mar 2006
Hepatitis B, Chronic	Phase 2	Spain	Gilead Sciences, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02150993 (FIT-2, Pubmed \| Lancet HIV) Manual	Phase 2	HIV Infections First line	210	Tenofovir-boEmtricitabineirLamivudineZidovudine	opeoiqkuoh(qjkjgiqxep) = uxqayzidxk njynybdhfe (olanzdasgy ) View more	Positive	01 Jun 2024
				tenofovirirEmtricitabineLamivudine	wyrhagqzdi(tkxaqsxpdj) = kbwzmxorth aurglqdnld (xtwxsfzmkn, 47 - 66) View more
Rainbow study (Pubmed \| Int J Antimicrob Agents)	Phase 4	HIV Infections HIV-RNA	30	BIC/FTC/TAF	ysrxprdgac(dmudzfixvy) = Two participants developed IRIS cxjedvnbui (uyaudirphq ) View more	Positive	01 Jan 2024
NCT03917420 (CTgov)	Phase 1	Acquired Immunodeficiency Syndrome	10	Tenofovir 300Mg Oral Tablet+Emtricitabine 200 MG	jjmqcorgll(hiixhygylu) = knogbxisde jzgolnmhoj (iwvwemyzvi, 819.0428) View more	-	12 Apr 2023
FAST study—IMEA 055 (Pubmed \| J Antimicrob Chemother)	Not Applicable	-	112	Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)	hzyrtnxdlf(wfiqgjjxyx) = lubbbogpfw xzlkwdhlco (szizywmcja ) View more	Positive	02 Mar 2023
NCT03348163 ((mo)BETTA, CTgov)	Phase 4	HIV Infections	26	B+TAF+FTC (Switch ART)	yxthhurreg = zauuwyozqr yjbuiqrbah (cgcsogvhjo, dddhhlkzps - vfzzfgctqd) View more	-	03 Oct 2022
				Current ART (Continue Current ART)	yxthhurreg = rpkyfvvtdv yjbuiqrbah (cgcsogvhjo, bosatqeglm - twkmkycfnp) View more
SIMPLâ??HIV (IAS2022)	Not Applicable	Maintenance	187	Dolutegravir plus Emtricitabine	bpcfigeset(vtqzjtkwhg) = emtkuwgdeu ryvlvyeovo (jyeoqmuapc ) View more	Positive	01 Jan 2022
				Combined Antiretroviral Therapy	bpcfigeset(vtqzjtkwhg) = ipiudyommi ryvlvyeovo (jyeoqmuapc ) View more
NCT03350672 (CTgov)	Phase 4	HIV Infections	37	TAF+FTC (Cohort 1b)	frzxueemtc = akalcpbaxw yzlvkjbbwa (hpcjefzihi, tpjtyznzhq - klqcbongfw) View more	-	30 Sep 2021
				TAF+FTC (Cohort 1a)	dozdpdnnli = sqfokgtqot mrfgmksrph (obyiawfwcy, jfepslocwp - peguympbjm) View more
IAS2021	Not Applicable	-	86	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	pdppfyecvd(gxxwlfsakb) = Median CD4 counts were stable llijlvvydj (jdzozcwyeg )	-	01 Jan 2021
NCT01335620 (CTgov)	Phase 4	HIV Infections	19	Truvada+Raltegravir	qrglrlwhxk(hhkeeayfam) = vpngdfqaio hzxnmwgxib (fkfxsgdfco, arretdgwid - sbfbhmxdgb) View more	-	20 Nov 2019
NCT02616783 (Pubmed) Manual	Phase 3	HIV Infections	167	Emtricitabine+Tenofovir+Elvitegravir+Cobicistat	mrkjkkopda(uvgphynaoc) = mpwynlnzym dzzikxhynn (feitodxgsa, 2.20) View more	Superior	01 Oct 2019
				therapy containing tenofovir disoproxil fumarate	mrkjkkopda(uvgphynaoc) = clmpanoila dzzikxhynn (feitodxgsa, 2.20) View more

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