diclofenac

Trade name: voltaren

Small moleculeapproved

Approved

Jul 28, 1988

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class with anti-inflammatory, analgesic, and antipyretic properties. Contrary to the action of many traditional NSAIDs, diclofenac inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1. In addition diclofenac can inhibit the thromboxane-prostanoid receptor, affect arachidonic acid release and uptake, inhibit lipoxygenase enzymes, and activate the nitric oxide-cGMP antinociceptive pathway. Other novel mechanisms of action may include the inhibition of substrate P, inhibition of peroxisome proliferator activated receptor gamma (PPARgamma), blockage of acid-sensing ion channels, alteration of interleukin-6 production, and inhibition of N-methyl-D-aspartate (NMDA) receptor hyperalgesia. Similar to other NSAIDs, diclofenac is associated with serious dose-dependent gastrointestinal, cardiovascular, and renal adverse effects. Since its introduction in 1973, a number of different diclofenac-containing drug products have been developed with the goal of improving efficacy, tolerability, and patient convenience. Delayed- and extended-release forms of diclofenac sodium were initially developed with the goal of improving the safety profile of diclofenac and providing convenient, once-daily dosing for the treatment of patients with chronic pain. New drug products consisting of diclofenac potassium salt were associated with faster absorption and rapid onset of pain relief. These include diclofenac potassium immediate-release tablets, diclofenac potassium liquid-filled soft gel capsules, and diclofenac potassium powder for oral solution. The advent of topical formulations of diclofenac enabled local treatment of pain and inflammation while minimizing systemic absorption of diclofenac. SoluMatrix diclofenac, consisting of submicron particles of diclofenac free acid and a proprietary combination of excipients, was developed to provide analgesic efficacy at reduced doses associated with lower systemic absorption. The drug's likely impact on the Asian vulture population was widely reported. The dramatic mortality was attributed largely to renal failure caused by exposure to diclofenac in livestock carcasses on which the birds fed. Although not the most endearing species, vultures are important environmental scavengers and, since veterinary use of diclofenac was stopped in the region in 2006, the decline in vulture numbers has slowed. — NCATS

Clinical trial activity

416 trials · 354 clinical orgs · 73 marketing orgs

Phase 1

Phase 2

152

Phase 3

110

Phase 4

103

Earliest trial started Apr 1, 1993 (NCT00913224)

Timeline

1980s

Jul 28, 1988
Earliest FDA Approval
Jul 28, 1988
Novartis — NDA Secondary Org

1990s

Jan 1, 1993
Sandoz — Earliest Phase 1 Sponsor(trial)
Jun 29, 1995
Roxane Laboratories — Marketing Organization
Jun 29, 1995
Boehringer Ingelheim — Marketing Organization
Sep 28, 1995
CASI Pharmaceuticals, Inc. — Marketing Organization
Sep 28, 1995
Chartwell Pharmaceuticals — Marketing Organization
Mar 26, 1996
Actavis — Marketing Organization
Aug 15, 1996
Teva — Marketing Organization
Dec 24, 1997
G D Searle — Marketing Organization
Dec 24, 1997
Pfizer — NDA Secondary Org
Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
May 4, 1998
Falcon Pharmaceuticals — NDA Secondary Org
Nov 13, 1998
Ionis Pharmaceuticals, Inc. — Marketing Organization
Feb 26, 1999
Allied Pharmaceutical Services — Marketing Organization
Feb 26, 1999
Micro Labs Ltd India — Marketing Organization
Jul 26, 1999
Apicore — Marketing Organization
Jul 26, 1999
Mylan — Marketing Organization
Jul 29, 1999
Pliva — Marketing Organization

2000s

Feb 11, 2000
Aton — Marketing Organization
Oct 16, 2000
Fougera — NDA Secondary Org
Feb 23, 2001
Sandoz — Marketing Organization
Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
Feb 21, 2002
Sun Pharmaceuticals — Marketing Organization
Nov 6, 2002
Dexcel Pharma Technologies Ltd. — Marketing Organization
Mar 18, 2004
Apotex — Marketing Organization
Mar 18, 2004
Amici — Marketing Organization
Mar 18, 2004
ANDA Repository — Marketing Organization
Jun 8, 2007
Unique Pharmaceuticals Ltd, India — Marketing Organization
Oct 17, 2007
GlaxoSmithKline — NDA Secondary Org
Dec 28, 2007
Bausch & Lomb — Marketing Organization
Dec 28, 2007
Rising Pharmaceuticals — Marketing Organization
Feb 6, 2008
Novartis — Marketing Organization
Apr 17, 2008
Akorn, Inc. — Marketing Organization
Nov 13, 2008
Rubicon Research — Marketing Organization
Jun 16, 2009
Assertio — NDA Secondary Org
Nov 4, 2009
Nuvo Research Inc. — NDA Secondary Org

2010s

Oct 18, 2013
Zyla Life Sciences — NDA Secondary Org
Oct 18, 2013
Zyla Life Sciences — Marketing Organization
Oct 28, 2013
Tolmar Inc. — Marketing Organization
Jan 16, 2014
Horizon Pharma — Marketing Organization
Jan 16, 2014
Horizon Pharma — NDA Secondary Org
Mar 14, 2014
Exela Pharma Sciences, LLC. — Marketing Organization
Nov 24, 2014
TWi Biotechnology, Inc. — Marketing Organization
Nov 24, 2014
Watson Pharmaceuticals — Marketing Organization
Nov 26, 2014
Taro Pharmaceuticals — Marketing Organization
Dec 23, 2014
Javelin Pharmaceuticals — NDA Secondary Org
Dec 23, 2014
Hospira — NDA Secondary Org
Jul 8, 2015
Pharmaceutical Associates — Marketing Organization
Jul 8, 2015
Teligent Pharmaceuticals — Marketing Organization
Aug 20, 2015
Lupin — Marketing Organization
Oct 14, 2015
Paddock Laboratories — Marketing Organization
Nov 16, 2015
Altair Therapeutics — Marketing Organization
Dec 2, 2015
Allergan PLC (2015) — Marketing Organization
Dec 9, 2015
Novel Anti-Infective Technologies, LLC — Marketing Organization
Feb 23, 2016
Bionpharma Inc — Marketing Organization
Mar 18, 2016
Amneal Pharmaceuticals — Marketing Organization
May 2, 2016
Par Pharmaceuticals — Marketing Organization
May 2, 2016
Bristol-Myers Squibb — Marketing Organization
Sep 13, 2016
Glenmark Pharmaceuticals — Marketing Organization
Oct 28, 2016
VersaPharm — Marketing Organization
Aug 7, 2017
RiconPharma — Marketing Organization
Aug 7, 2017
Novast Labs — Marketing Organization
Apr 17, 2018
Cadila Healthcare — Marketing Organization
Apr 17, 2018
Zydus Discovery DMCC — Marketing Organization
Jul 27, 2018
Perrigo — Marketing Organization
Jul 27, 2018
Padagis Us — Marketing Organization
Aug 3, 2018
Cipla — Marketing Organization
Nov 21, 2018
Hi Tech Pharmaceuticals — Marketing Organization
Dec 19, 2018
IBSA Institut Biochimique SA — NDA Secondary Org
May 6, 2019
Aurobindo Pharma — Marketing Organization
Dec 3, 2019
Strides Pharma Science — Marketing Organization

2020s

Jan 27, 2020
Encube Ethicals Pvt. Ltd. — Marketing Organization
Feb 19, 2020
Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization
Mar 4, 2022
Annora Pharma — Marketing Organization
May 11, 2022
Umedica Labs Pvt Ltd — Marketing Organization
Jul 20, 2022
Alkem Labs Ltd — Marketing Organization
Jul 27, 2022
Alembic — Marketing Organization
Mar 15, 2023
Senores Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
- Prostaglandin G/H synthase 2 (PTGS2) ↗
- Prostaglandin G/H synthase 1 (PTGS1) ↗
- Cyclooxygenase-1
- Cyclooxygenase-2

Combination products

arthrotec
with misoprostol

Approval history

approvedJul 28, 1988

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)CC1=CC=CC=C1NC2=C(Cl)C=CC=C2Cl

Mol. weight: 296.149 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Over the Counter

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

[2-(2,6-dichloroanilino)phenyl]acetic acid
[2-(2,6-dichloroanilino)phenyl]acetic acid
2-((2,6-dichlorophenyl)amino)benzeneacetic acid
2-((2,6-dichlorophenyl)amino)benzeneacetic acid
abitren
abitren
acoflam
acoflam ret
acoflam sr
arthronac
arthrotec
arthrotec 50
arthrotec 75
cambia
cambia
cataflam
cataflam
cgp-45840b
cgp-45840b
closteril 100
defanac
defanac retard
defanac sr
dexomon ret
dexomon sr
dhep
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac
diclofenac 1-(2-hydroxyethyl)pyrrolidinium salt
diclofenac acid
diclofenac acid
diclofenac calcium
diclofenac calcium
diclofenac calcium
diclofenac calcium
diclofenac calcium
diclofenac calcium
diclofenac diethylamine
diclofenac diethylamine
diclofenac diethylamine
diclofenac epolamine
diclofenac epolamine
diclofenac epolamine
diclofenac epolamine
diclofenac-epolamine
diclofenac-epolamine
diclofenac hydroxyethylpyrrolidine
diclofenac hydroxyethylpyrrolidine
diclofenac-n-(2-hydroxyethyl) pyrrolidine
diclofenaco
diclofenaco
diclofenac potassium
diclofenac potassium
diclofenac potassium
diclofenac potassium
diclofenac potassium
diclofenac sod
diclofenac sod
diclofenac sodium
diclofenac sodium
diclofenac sodium
diclofenac sodium
diclofenac sodium
diclofenacum
diclofenacum
diclofenamic acid
dicloflex
dicloflex ret
dicloflex sr
diclomax ret
diclomax sr
diclotard 100 mr
diclotard 75 mr
diclovol
diclovol ret
diclovol sr
diclozip 25
diclozip 50
diep
difenor xl
digenac xl 100
econac
econac sr
econac xl
enstar sr
enstar xl
enzed
epolamine
epolamine
epolamine
epolamine hydrochloride
fenactol
fenactol ret
fenactol sr
flamatak mr
flamrase
flamrase sr
flector
flector
flector
flector patch
flexotard mr
gdc 695
gp-45840
gp-45840
hydroxyethylpyrrolidine
hydroxyethylpyrrolidine
isclofen
las41007
lofensaid 25
lofensaid 50
lofensaid ret 100
lofensaid ret 75
masidemen
misofen
mobigel
mobigel paineze
motifene
n-(2-hydroxyethyl)-2,5-(14c)-pyrrolidine
n-(2-hydroxyethyl)pyrrolidine
n-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate
pennsaid
pennsaid
potassium diclofenac
pro-513
rheumatac ret 75
rhumalgan
rhumalgan
rhumalgan cr 100
rhumalgan cr 75
rhumalgan sr
rhumalgan xl
slofenac
sodium diclofenac
sodium diclofenac
solaraze
solaraze
valdic 100 ret
valdic 75 ret
valenac
volraman
volsaid ret 100
volsaid ret 75
voltaren
voltaren
voltaren
voltaren
voltarene
voltarene
voltarene emulgel
voltarene l.p.
voltaren emulgel
voltarene ret
voltaren ophthalmic
voltaren ophthalmic
voltaren ret
voltaren xr
voltaren xr
voltaren-xr
voltaren-xr
voltarol
voltarol
voltarol
voltarol 12 hour emulgel p
voltarol active
voltarol emulgel
voltarol emulgel p
voltarol gel patch
voltarol joint pain
voltarol ophtha
voltarol pain-eze
voltarol pain-eze emulgel
voltarol pain-eze extra strgh
voltarol rapid
voltarol ret
voltarol sr
zipsor
zipsor

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07079969	Phase 2	Jan 31, 2026	University of Florida
NCT07145645	Phase 3	Sep 2, 2025	Hamilton Health Sciences Corporation, University of Calgary
NCT06989645	Phase 1/Phase 2 (Phase 2)	Aug 19, 2025	Clinical Trial Consultants AB, Synartro AB
NCT07178639	N/A	Aug 1, 2025	Nemocnice Kolín
NCT07101016	N/A	Aug 1, 2025	Cairo University
NCT07060976	N/A	Jul 21, 2025	Novamed Laboratories Pvt. Ltd., NovoBliss Research Pvt Ltd
NCT07131527	N/A	Jul 14, 2025	Sohag University
NCT07040709	N/A	Jun 8, 2025	Gaziosmanpasa University
NCT06982755	Phase 1/Phase 2 (Phase 2)	Jun 1, 2025	Hunan University of Traditional Chinese Medicine
NCT07071441	N/A	Jun 1, 2025	Air Force Military Medical University, China
NCT06942702	N/A	May 20, 2025	Mersin University
NCT06954181	N/A	Mar 26, 2025	Healeon Medical Inc
NCT06905561	N/A	Feb 13, 2025	Hainan Medical College
NCT07071012	N/A	Feb 1, 2025	Hacettepe University
NCT06693648	Phase 3	Jan 31, 2025	Amzell, Nordic Bioscience
NCT07203651	N/A	Jan 1, 2025	Government of Pakistan
NCT06731270	Phase 2	Jan 1, 2025	Emory University, National Cancer Institute (NCI)
NCT06731556	Phase 3	Dec 15, 2024	Bezmialem University
NCT06574191	N/A	Dec 10, 2024	Harvard University, National Institute on Aging (NIA), University of California, Davis
NCT06636227	Phase 1	Dec 1, 2024	University of Maryland

Showing 20 of 416 trials

Page 1 / 21

Organizations

Research & Development (354)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Cairo University	Academic/Hospital	24	23	5	2015
Novartis	For profit	22	21	4	2003
Merck	For profit	14	11	3	1998
Pfizer	For profit	13	13	2	2002
Assiut University	Academic/Hospital	7	7	3	2016
GlaxoSmithKline	For profit	7	7	3	2013
Javelin Pharmaceuticals	For profit	7	7	2	2006
ZetrOZ, Inc.	For profit	7	7	2	2019
Boehringer Ingelheim	For profit	6	6	3	1999
Cerimon Pharmaceuticals	For profit	5	5	1	2007
IBSA Institut Biochimique SA	For profit	5	5	3	2009
Iroko	For profit	5	5	2	2009
PPD	For profit	5	0	1	2007
Tel Aviv University	Academic/Hospital	5	5	2	2004
Ain Shams University	Academic/Hospital	4	4	4	2016
Assertio	For profit	4	3	1	2013
Hamad Medical Corporation	For profit	4	4	2	2010
Harvard University	Academic/Hospital	4	3	3	2011
Yeshiva University	Academic/Hospital	4	2	3	2006
Almirall	For profit	3	3	3	2009

354 organizations

Page 1 / 18

Marketing (98)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Mar 18, 2004
Actavis	For profit	MKTG	Mar 26, 1996
Actavis	For profit	SYN	Jul 9, 2012
Actavis	For profit	SYN	Nov 2, 2017
Actavis	For profit	SYN	Dec 2, 2015
Akorn, Inc.	For profit	MKTG	Apr 17, 2008
Alembic	For profit	MKTG	Jul 27, 2022
Alembic	For profit	SYN	Jul 27, 2022
Alkem Labs Ltd	For profit	MKTG	Jul 20, 2022
Allergan PLC (2015)	For profit	MKTG	Dec 2, 2015
Allied Pharmaceutical Services	For profit	MKTG	Feb 26, 1999
Altair Therapeutics	For profit	MKTG	Nov 16, 2015
Amici	For profit	MKTG	Mar 18, 2004
Amneal Pharmaceuticals	For profit	MKTG	Mar 18, 2016
Amneal Pharmaceuticals	For profit	SYN	Aug 18, 2022
Annora Pharma	For profit	MKTG	Mar 4, 2022
Apicore	For profit	MKTG	Jul 26, 1999
Apotex	For profit	MKTG	Mar 18, 2004
Apotex	For profit	SYN	Nov 13, 2008
Assertio	For profit	NDA2	Jun 16, 2009
Aton	For profit	MKTG	Feb 11, 2000
Aurobindo Pharma	For profit	SYN	Oct 19, 2021
Aurobindo Pharma	For profit	SYN	Feb 12, 2002
Aurobindo Pharma	For profit	MKTG	May 6, 2019
Bausch & Lomb	For profit	MKTG	Dec 28, 2007
Bionpharma Inc	For profit	MKTG	Feb 23, 2016
Bionpharma Inc	For profit	SYN	Feb 23, 2016
Boehringer Ingelheim	For profit	MKTG	Jun 29, 1995
Bristol-Myers Squibb	For profit	MKTG	May 2, 2016
CASI Pharmaceuticals, Inc.	For profit	MKTG	Sep 28, 1995
Cadila Healthcare	For profit	MKTG	Apr 17, 2018
Chartwell Pharmaceuticals	For profit	MKTG	Sep 28, 1995
Ciba-Geigy	For profit	NDA	—
Cipla	For profit	MKTG	Aug 3, 2018
Dexcel Pharma Technologies Ltd.	For profit	MKTG	Nov 6, 2002
Encube Ethicals Pvt. Ltd.	For profit	MKTG	Jan 27, 2020
Exela Pharma Sciences, LLC.	For profit	MKTG	Mar 14, 2014
Falcon Pharmaceuticals	For profit	NDA2	May 4, 1998
Fougera	For profit	NDA2	Oct 16, 2000
G D Searle	For profit	MKTG	Dec 24, 1997
GlaxoSmithKline	For profit	NDA2	Oct 17, 2007
Glenmark Pharmaceuticals	For profit	MKTG	Sep 13, 2016
Hi Tech Pharmaceuticals	For profit	MKTG	Nov 21, 2018
Horizon Pharma	For profit	MKTG	Jan 16, 2014
Horizon Pharma	For profit	NDA2	Jan 16, 2014
Hospira	For profit	NDA2	Dec 23, 2014
IBSA Institut Biochimique SA	For profit	NDA2	Dec 19, 2018
IBSA Institut Biochimique SA	For profit	SYN	Jan 31, 2007
Ionis Pharmaceuticals, Inc.	For profit	MKTG	Nov 13, 1998
Javelin Pharmaceuticals	For profit	NDA2	Dec 23, 2014
Lupin	For profit	MKTG	Aug 20, 2015
Lupin	For profit	SYN	Sep 21, 2022
Micro Labs Ltd India	For profit	SYN	Feb 26, 1999
Micro Labs Ltd India	For profit	MKTG	Feb 26, 1999
Mylan	For profit	MKTG	Jul 26, 1999
Mylan	For profit	SYN	Feb 12, 2002
Mylan	For profit	SYN	Jun 18, 2019
Novartis	For profit	NDA2	Jul 28, 1988
Novartis	For profit	MKTG	Feb 6, 2008
Novast Labs	For profit	MKTG	Aug 7, 2017
Novel Anti-Infective Technologies, LLC	For profit	MKTG	Dec 9, 2015
Nuvo Research Inc.	For profit	NDA2	Nov 4, 2009
Padagis Us	For profit	MKTG	Jul 27, 2018
Paddock Laboratories	For profit	MKTG	Oct 14, 2015
Par Pharmaceuticals	For profit	MKTG	May 2, 2016
Perrigo	For profit	MKTG	Jul 27, 2018
Perrigo	For profit	MKTG	May 16, 2019
Pfizer	For profit	NDA2	Dec 24, 1997
Pharmaceutical Associates	For profit	MKTG	Jul 8, 2015
Pliva	For profit	MKTG	Jul 29, 1999
RiconPharma	For profit	MKTG	Aug 7, 2017
Rising Pharmaceuticals	For profit	SYN	Jun 18, 2019
Rising Pharmaceuticals	For profit	MKTG	Dec 28, 2007
Rising Pharmaceuticals	For profit	SYN	Dec 28, 2007
Roxane Laboratories	For profit	MKTG	Jun 29, 1995
Rubicon Research	For profit	MKTG	Nov 13, 2008
Sandoz	For profit	MKTG	Feb 23, 2001
Sandoz	For profit	SYN	Feb 6, 2008
Senores Pharms	For profit	MKTG	Mar 15, 2023
Strides Pharma Science	For profit	MKTG	Dec 3, 2019
Sun Pharmaceuticals	For profit	MKTG	Feb 21, 2002
TWi Biotechnology, Inc.	For profit	MKTG	Nov 24, 2014
Taro Pharmaceuticals	For profit	MKTG	Nov 26, 2014
Teligent Pharmaceuticals	For profit	MKTG	Jul 8, 2015
Teligent Pharmaceuticals	For profit	SYN	Jul 8, 2015
Teva	For profit	MKTG	Aug 15, 1996
Teva	For profit	SYN	Jun 25, 1997
Teva	For profit	SYN	Nov 27, 1998
Tolmar Inc.	For profit	MKTG	Oct 28, 2013
Umedica Labs Pvt Ltd	For profit	MKTG	May 11, 2022
Unique Pharmaceuticals Ltd, India	For profit	MKTG	Jun 8, 2007
Unique Pharmaceuticals Ltd, India	For profit	SYN	Jun 8, 2007
VersaPharm	For profit	MKTG	Oct 28, 2016
Watson Pharmaceuticals	For profit	MKTG	Nov 24, 2014
Yung Shin Pharm. Ind. Co., Ltd.	For profit	MKTG	Feb 19, 2020
Zydus Discovery DMCC	For profit	MKTG	Apr 17, 2018
Zyla Life Sciences	For profit	NDA2	Oct 18, 2013
Zyla Life Sciences	For profit	MKTG	Oct 18, 2013