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rilpivirine

Trade name: edurant

Small moleculeapproved

Approved

May 20, 2011

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used for the treatment of HIV-1 infections in treatment-naive patients. It is active against wild-type and NNRTI-resistant HIV-1. Rilpivirine is a diarylpyrimidinethat inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ. — NCATS

Clinical trial activity

116 trials · 73 clinical orgs · 11 marketing orgs

Phase 1
37
Phase 2
57
Phase 3
42
Phase 4
19

Earliest trial started Jan 1, 2002 (NCT00537966)

Timeline

2000s

  1. Oct 29, 2004

    Johnson and Johnson — IND Organization

  2. Oct 29, 2004

    Johnson and Johnson — IND Organization

  3. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. May 20, 2011

    Johnson and Johnson — Earliest FDA Approval

  2. May 20, 2011

    Johnson and Johnson — NDA Secondary Org

  3. May 20, 2011

    Johnson and Johnson — NDA Organization

  4. Aug 10, 2011

    Gilead Sciences — Marketing Organization

  5. Aug 10, 2011

    Gilead Sciences — NDA Secondary Org

  6. Sep 29, 2015

    Strides Pharma Science — Marketing Organization

  7. Nov 20, 2017

    Mylan — Marketing Organization

  8. Nov 21, 2017

    ViiV Healthcare — Marketing Organization

  9. Nov 21, 2017

    ViiV Healthcare — NDA Secondary Org

2020s

  1. Sep 27, 2022

    Cipla — Marketing Organization

  2. Jan 13, 2023

    Lupin — Marketing Organization

  3. Aug 20, 2025

    Somerset Therapeutics LLC — Marketing Organization

  4. Jan 29, 2026

    Somerset Pharmaceuticals — Marketing Organization

  5. Jan 30, 2026

    Apotex — Marketing Organization

  6. Mar 4, 2026

    Laurus Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 20, 2011

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cc(/C=C/C#N)cc(C)c1Nc1ccnc(Nc2ccc(C#N)cc2)n1
Mol. weight
366.43 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 4-{[4-({4-[(e)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile
  • 4-{[4-({4-[(e)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile
  • edurant
  • edurant
  • edurant
  • edurant
  • emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide
  • emtricitabine / rilpivirine hydrochloride /tenofovir disoproxil fumarate
  • r-278474
  • r-278474
  • rilipivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine
  • rilpivirine hcl
  • rilpivirine hcl
  • rilpivirine hcl
  • rilpivirine hydrochloride
  • rilpivirine hydrochloride
  • rilpivirine hydrochloride
  • rilpivirine hydrochloride
  • rilpivirine hydrochloride
  • rllpivirine
  • tmc278
  • tmc278
  • tmc-278
  • tmc-278
  • tmc278-hydrochloride
  • tmc278-hydrochloride
  • tmc278la

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06646562Phase 4Mar 3, 2025Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, ViiV Healthcare
NCT06501781N/AJan 31, 2025University of Maryland
NCT06694805Phase 3Dec 2, 2024ViiV Healthcare
NCT06336434Phase 1/Phase 2 (Phase 2)Sep 24, 2024National Institute of Allergy and Infectious Diseases (NIAID)
NCT06468995Phase 3Sep 1, 2024GlaxoSmithKline, Vita-Salute University of Milano. Italy
NCT06411223Phase 2Aug 1, 2024ViiV Healthcare, Yale University
NCT06507059Phase 3Jul 19, 2024Chang Gung University, Taoyuan General Hospital
NCT06185452Phase 4Sep 26, 2023FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
NCT05917509Phase 3Jul 6, 2023GlaxoSmithKline, PPD, ViiV Healthcare
NCT05674656Phase 1/Phase 2 (Phase 2)Jun 1, 2023ViiV Healthcare
NCT05898841Phase 4May 26, 2023Fundacion SEIMC-GESIDA
NCT05660980Phase 1/Phase 2 (Phase 2)May 1, 2023National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
NCT05601128Phase 3Jan 1, 2023Allegheny Health Network
NCT04973254Phase 4Dec 31, 2022Boston University, ViiV Healthcare
NCT05546242Phase 3Nov 30, 2022Janssen Pharmaceutica NV, Medical Research Council-UVRI Uganda Research Unit on AIDS
NCT05896748Phase 3Nov 8, 2022GlaxoSmithKline, Janssen Pharmaceutica NV, ViiV Healthcare
NCT05154747Phase 3Aug 31, 2022Africa Health Research Institute, European and Developing Countries Clinical Trials Partnership (EDCTP), Johnson and Johnson, Medical Research Council-UVRI Uganda Research Unit on AIDS, PENTA Foundation, Radboud University, University of London, University of York, ViiV Healthcare
NCT05991622Early Phase 1 (Phase 1)Apr 1, 2022Rhode Island Hospital
NCT07001488Phase 1Feb 21, 2022Government of China
NCT05112939Phase 1Nov 3, 2021Janssen Pharmaceutica NV
Showing 20 of 116 trials
Page 1 / 6

Organizations

Research & Development (73)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ViiV HealthcareFor profit292352011
Janssen Pharmaceutica NVFor profit28352009
Johnson and JohnsonFor profit191542009
TibotecFor profit151532005
Gilead SciencesFor profit131032010
GlaxoSmithKlineFor profit12032012
National Institute of Allergy and Infectious Diseases (NIAID)Government9542010
St Stephens Aids TrustAcademic/Hospital4442010
Indiana UniversityAcademic/Hospital3222012
Mahidol UniversityAcademic/Hospital3322015
National Institutes of Health (NIH)Government3022010
University of LondonAcademic/Hospital3232010
University of NebraskaAcademic/Hospital3022018
Makerere UniversityAcademic/Hospital2212018
Medical Research Council-UVRI Uganda Research Unit on AIDSAcademic/Hospital2112022
MerckFor profit2122011
National Institute of Mental Health (NIMH)Government2012014
University of Alabama, BirminghamAcademic/Hospital2022018
University of BarcelonaAcademic/Hospital2222015
University of LiverpoolAcademic/Hospital2012018
73 organizations
Page 1 / 4

Marketing (16)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGJan 30, 2026
CiplaFor profitMKTGSep 27, 2022
Gilead SciencesFor profitMKTGAug 10, 2011
Gilead SciencesFor profitNDA2Aug 10, 2011
Johnson and JohnsonFor profitNDA2May 20, 2011
Johnson and JohnsonFor profitINDOct 29, 2004
Johnson and JohnsonFor profitNDAMay 20, 2011
Laurus Labs LtdFor profitMKTGMar 4, 2026
LupinFor profitMKTGJan 13, 2023
MylanFor profitMKTGNov 20, 2017
MylanFor profitSYNMay 20, 2025
Somerset PharmaceuticalsFor profitMKTGJan 29, 2026
Somerset Therapeutics LLCFor profitMKTGAug 20, 2025
Strides Pharma ScienceFor profitMKTGSep 29, 2015
ViiV HealthcareFor profitMKTGNov 21, 2017
ViiV HealthcareFor profitNDA2Nov 21, 2017