fentanyl

Trade name: Innovar

Small moleculeapproved

Approved

Feb 19, 1968

Methestrol is a nonsteroidal synthetic estrogen that has never been marketed. — NCATS

Clinical trial activity

1,009 trials · 541 clinical orgs · 33 marketing orgs

Phase 1
79
Phase 2
215
Phase 3
164
Phase 4
319

Earliest trial started May 1, 1986 (NCT00269737)

Timeline

1960s

  1. Feb 19, 1968

    Akorn, Inc. — Earliest FDA Approval

  2. Feb 19, 1968

    Akorn, Inc. — NDA Secondary Org

  3. Feb 19, 1968

    Rising Pharmaceuticals — Marketing Organization

  4. Feb 19, 1968

    Akorn, Inc. — NDA Organization

1980s

  1. Jul 11, 1984

    Hikma — Marketing Organization

  2. Jul 11, 1984

    West-Ward Pharmaceutical — NDA Secondary Org

  3. Jul 11, 1984

    Hikma — NDA Secondary Org

  4. Jan 12, 1985

    Hospira — NDA Secondary Org

  5. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

  6. May 4, 1988

    Hospira — Marketing Organization

1990s

  1. Apr 30, 1990

    Abbott — Marketing Organization

  2. Aug 7, 1990

    Johnson and Johnson — NDA Secondary Org

  3. Oct 4, 1993

    Cephalon — NDA Secondary Org

  4. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  5. Feb 3, 1998

    Dr. Reddy's Laboratories — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. May 22, 2006

    The Medicines Company — NDA Secondary Org

  3. Aug 4, 2006

    Lavipharm Labs — Marketing Organization

  4. Aug 20, 2007

    Mayne Pharma — Marketing Organization

  5. Oct 20, 2008

    Aveva Drug Delivery Systems — Marketing Organization

  6. Jul 16, 2009

    BioDelivery Sciences International — NDA Secondary Org

  7. Jul 16, 2009

    ADALVO — Marketing Organization

  8. Jul 16, 2009

    ADALVO — NDA Secondary Org

  9. Oct 16, 2009

    Noven Therapeutics — Marketing Organization

  10. Oct 16, 2009

    Hisamitsu Pharmaceutical Co., Inc. — Marketing Organization

  11. Oct 30, 2009

    Par Pharmaceuticals — Marketing Organization

  12. Oct 30, 2009

    Specgx Llc — Marketing Organization

2010s

  1. Jan 7, 2011

    Sentynl Theraps Inc — NDA Secondary Org

  2. Jan 7, 2011

    Watson Pharmaceuticals — Marketing Organization

  3. Jun 30, 2011

    Elefsee Pharms Intl — NDA Secondary Org

  4. Jun 30, 2011

    MMB Healthcare — Marketing Organization

  5. Jun 30, 2011

    MMB Healthcare — NDA Secondary Org

  6. Jan 4, 2012

    Insys Therapeutics Inc — NDA Secondary Org

  7. Mar 4, 2015

    Mylan — Marketing Organization

  8. Nov 4, 2016

    3M — Marketing Organization

  9. Nov 4, 2016

    Kindeva — Marketing Organization

  10. Nov 17, 2017

    Actavis — Marketing Organization

  11. Nov 17, 2017

    Allergan PLC (2015) — Marketing Organization

  12. May 3, 2019

    Fresenius — Marketing Organization

2020s

  1. Jan 24, 2023

    Zydus Discovery DMCC — Marketing Organization

  2. Feb 8, 2023

    Exela Pharma Sciences, LLC. — Marketing Organization

  3. Feb 8, 2023

    Exela Pharma Sciences, LLC. — NDA Secondary Org

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewFeb 19, 1968

Chemistry & pharmacology

Loading structure…

SMILES

CCC(C(CC)C1=CC(C)=C(O)C=C1)C2=CC(C)=C(O)C=C2
Mol. weight
298.4192 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Black box warning

Sources

Also known as

  • 1-phenethyl-4-(n-phenylpropionamido)piperidine
  • 1-phenethyl-4-(n-phenylpropionamido)piperidine
  • 1-phenethyl-4-n-propionylanilinopiperidine
  • 1-phenethyl-4-n-propionylanilinopiperidine
  • abstral
  • abstral
  • actiq
  • actiq
  • ad 923
  • aerolef
  • aerolef
  • breakyl
  • duragesic
  • duragesic
  • duragesic
  • duragesic-100
  • duragesic-100
  • duragesic-12
  • duragesic-12
  • duragesic-25
  • duragesic-25
  • duragesic-50
  • duragesic-50
  • duragesic-75
  • duragesic-75
  • durogesic
  • durogesic
  • durogesic
  • durogesic dtrans
  • effentora
  • effentora
  • effentora
  • fencino
  • fentalis reservoir
  • fentanil
  • fentanil
  • fentanil
  • fentanila
  • fentanila
  • fentanilo
  • fentanilo
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl
  • fentanyl-100
  • fentanyl-100
  • fentanyl-12
  • fentanyl-12
  • fentanyl-25
  • fentanyl-25
  • fentanyl-50
  • fentanyl-50
  • fentanyl-75
  • fentanyl-75
  • fentanyl cii
  • fentanyl cii
  • fentanyl citrate
  • fentanyl citrate
  • fentanyl citrate
  • fentanyl citrate
  • fentanyl citrate
  • fentanyl citrate
  • fentanyl citrate preservative free
  • fentanyl citrate preservative free
  • fentanyl-droperidol
  • fentanyl hcl
  • fentanyl hcl
  • fentanyl hcl
  • fentanyl hydrochloride
  • fentanyl hydrochloride
  • fentanyl hydrochloride
  • fentanyl hydrochloride
  • fentanyl hydrochloride
  • fentanyl / midazolam
  • fentanylum
  • fentanylum
  • fentora
  • fentora
  • innovar
  • innovar
  • innovar
  • innovar-vet
  • instanyl
  • ionsys
  • ionsys
  • jns020qd
  • jns020qd
  • lazanda
  • lazanda
  • leptanal
  • leptanal
  • leptofen
  • matrifen
  • matrifen
  • mcn-jr-4263-49
  • mcn-jr-4263-49
  • mezolar matrix
  • mylafent
  • n-(1-phenethyl-4-piperidinyl)-n-phenylpropionamide
  • n-(1-phenethyl-4-piperidinyl)-n-phenylpropionamide
  • n-(1-phenethyl-4-piperidyl)propionanilide
  • n-(1-phenethyl-4-piperidyl)propionanilide
  • n-(1-phenethyl-piperidin-4-yl)-n-phenyl-propionamide
  • n-(1-phenethyl-piperidin-4-yl)-n-phenyl-propionamide
  • n-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide
  • n-(1-phenethylpiperidin-4-yl)-n-phenylpropionamide
  • n-phenethyl-4-(n-propionylanilino)piperidine
  • n-phenethyl-4-(n-propionylanilino)piperidine
  • n-phenyl-n-(1-(2-phenylethyl)-4-piperidinyl)propanamide
  • n-phenyl-n-(1-(2-phenylethyl)-4-piperidinyl)propanamide
  • n-phenyl-n-(1-(2-phenylethyl)-4-piperidinyl)propanamide. 2-hydroxy-1,2,3-propanetricarboxylate mixt. with 1-(1-(4-(4-fluorophenyl)-4-oxobutyl)-1,2,3,6- tetrahydro-4-pyridinyl)-1,3-dihydro-2h-benzimidazol- 2-one
  • onsolis
  • opiodur
  • oralet
  • oralet
  • osmach
  • osmanil
  • pecfent
  • pecfent
  • phentanyl
  • phentanyl
  • r-4263
  • r-4263
  • recivit
  • sublimaze
  • sublimaze
  • sublimaze preservative free
  • sublimaze preservative free
  • subsys
  • subsys
  • talamonal
  • thalamonal
  • thalamonal
  • thalamonal
  • tilofyl
  • victanyl
  • yemex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276906Phase 4Jan 31, 2026University of South Alabama
NCT07248202N/ADec 31, 2025Cairo University
NCT07262242N/ADec 31, 2025Cairo University
NCT07299630Phase 3Dec 20, 2025Ain Shams University
NCT07304206N/ADec 8, 2025Inonu University
NCT07246447N/ANov 30, 2025Cairo University
NCT07224620Phase 2Nov 30, 2025Harvard University
NCT07214714Phase 4Nov 1, 2025Assiut University
NCT07276867N/AOct 20, 2025National Cancer Institute, Egypt
NCT07091123Phase 4Oct 13, 2025Case Western Reserve University
NCT07258628N/AOct 10, 2025Ankara Yildirim Beyazıt University
NCT07112430Phase 1/Phase 2 (Phase 2)Oct 1, 2025Canadian Institutes of Health Research (CIHR), Dalhousie University
NCT06953453Phase 1Sep 23, 2025Jiao Tong University, Lee's Pharmaceutical
NCT07182097N/ASep 19, 2025Konya City Hospital
NCT07117565Phase 4Sep 15, 2025Tribhuvan University
NCT07149545N/ASep 15, 2025Capital Medical University
NCT07161297Phase 4Sep 1, 2025Humanitas University
NCT07166666N/ASep 1, 2025Oman Medical Board Specialty (OMSB)
NCT07076368Phase 3Aug 31, 2025University of California, San Francisco
NCT07114263N/AAug 31, 2025Tanta University
Showing 20 of 1,009 trials
Page 1 / 51

Organizations

Research & Development (541)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cairo UniversityAcademic/Hospital494652014
Johnson and JohnsonFor profit373451996
Ain Shams UniversityAcademic/Hospital363642016
Assiut UniversityAcademic/Hospital282852007
Mansoura UniversityAcademic/Hospital262542014
Janssen Pharmaceutica NVFor profit18031999
Yonsei UniversityAcademic/Hospital181832009
Tanta UniversityAcademic/Hospital151522014
CephalonFor profit131332004
Istanbul Medipol UniversityAcademic/Hospital131322018
Insys Therapeutics IncFor profit121042007
Seoul National UniversityAcademic/Hospital121232010
University of Texas at HoustonAcademic/Hospital121142007
University of Sao PauloAcademic/Hospital111132004
Icahn School of Medicine at Mount SinaiAcademic/Hospital10732006
Zagazig UniversityAcademic/Hospital101032019
AlzaFor profit9841986
Duke UniversityAcademic/Hospital9832006
Jiao Tong UniversityAcademic/Hospital9632014
Johns Hopkins UniversityAcademic/Hospital9842003
541 organizations
Page 1 / 28

Marketing (44)

OrganizationOrg typeRelationshipDate
3MFor profitMKTGNov 4, 2016
ADALVOFor profitMKTGJul 16, 2009
ADALVOFor profitNDA2Jul 16, 2009
AbbottFor profitMKTGApr 30, 1990
ActavisFor profitMKTGNov 17, 2017
ActavisFor profitSYNAug 20, 2007
Akorn, Inc.For profitNDA2Feb 19, 1968
Akorn, Inc.For profitNDAFeb 19, 1968
Allergan PLC (2015)For profitMKTGNov 17, 2017
AstraZenecaFor profitMKTG
Aveva Drug Delivery SystemsFor profitMKTGOct 20, 2008
BioDelivery Sciences InternationalFor profitNDA2Jul 16, 2009
CephalonFor profitNDA2Oct 4, 1993
Dr. Reddy's LaboratoriesFor profitMKTGFeb 3, 1998
Dr. Reddy's LaboratoriesFor profitSYNAug 22, 2022
Elefsee Pharms IntlFor profitNDA2Jun 30, 2011
Exela Pharma Sciences, LLC.For profitMKTGFeb 8, 2023
Exela Pharma Sciences, LLC.For profitNDA2Feb 8, 2023
FreseniusFor profitMKTGMay 3, 2019
HikmaFor profitMKTGJul 11, 1984
HikmaFor profitSYNJul 11, 1984
HikmaFor profitNDA2Jul 11, 1984
Hisamitsu Pharmaceutical Co., Inc.For profitMKTGOct 16, 2009
HospiraFor profitNDA2Jan 12, 1985
HospiraFor profitMKTGMay 4, 1988
Insys Therapeutics IncFor profitNDA2Jan 4, 2012
Johnson and JohnsonFor profitNDA2Aug 7, 1990
KindevaFor profitMKTGNov 4, 2016
Lavipharm LabsFor profitMKTGAug 4, 2006
MMB HealthcareFor profitMKTGJun 30, 2011
MMB HealthcareFor profitNDA2Jun 30, 2011
Mayne PharmaFor profitMKTGAug 20, 2007
MylanFor profitMKTGMar 4, 2015
MylanFor profitSYNJan 28, 2005
Noven TherapeuticsFor profitMKTGOct 16, 2009
Par PharmaceuticalsFor profitMKTGOct 30, 2009
Rising PharmaceuticalsFor profitMKTGFeb 19, 1968
Sentynl Theraps IncFor profitNDA2Jan 7, 2011
Specgx LlcFor profitMKTGOct 30, 2009
The Medicines CompanyFor profitNDA2May 22, 2006
Watson PharmaceuticalsFor profitMKTGJan 7, 2011
Watson PharmaceuticalsFor profitSYNFeb 3, 1998
West-Ward PharmaceuticalFor profitNDA2Jul 11, 1984
Zydus Discovery DMCCFor profitMKTGJan 24, 2023