isosorbide

Trade name: isordil

Small moleculeapproved

Approved

Nov 9, 1959

Isosorbide dinitrate is a medication used for heart failure, esophageal spasms, and to treat and prevent angina pectoris. It has been found to be particularly useful in heart failure due to systolic dysfunction together with hydralazine. It is taken by mouth or under the tongue. — Wikipedia

Clinical trial activity

84 trials · 107 clinical orgs · 41 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 1, 1990 (NCT00000478)

Timeline

1950s

Nov 9, 1959
American Home Products — Earliest FDA Approval
Nov 9, 1959
Bausch Health Companies — NDA Secondary Org
Nov 9, 1959
American Home Products — NDA Organization

1960s

Dec 20, 1961
Biovail — NDA Secondary Org
Jan 16, 1968
AstraZeneca — NDA Secondary Org

1970s

Jan 30, 1974
Alcon — NDA Secondary Org
Dec 1, 1978
Sun Pharmaceuticals — Marketing Organization

1980s

Dec 12, 1980
American Home Products — NDA Secondary Org
Mar 9, 1982
Hikma — Marketing Organization
Apr 28, 1982
Sandoz — Marketing Organization
Jul 20, 1982
Watson Pharmaceuticals — Marketing Organization
Jul 20, 1982
Ani Pharmaceuticals — Marketing Organization
Sep 28, 1982
Par Pharmaceuticals — Marketing Organization
Sep 28, 1982
Endo Pharmaceuticals — Marketing Organization
Feb 25, 1985
Teva — Marketing Organization
Feb 17, 1987
Superpharm — Marketing Organization
Sep 2, 1988
Auxillium — NDA Secondary Org

1990s

Jan 1, 1990
Earliest Phase 3 Sponsor(trial)
Dec 30, 1991
Dr. Reddy's Laboratories — NDA Secondary Org
Jun 30, 1993
Eci Pharmaceuticals Llc — Marketing Organization
Jun 30, 1993
Lannett Company, Inc. — NDA Secondary Org
Jun 30, 1993
Eci Pharmaceuticals Llc — NDA Secondary Org
Jun 30, 1993
Genus Oncology, LLC — Marketing Organization
Jun 30, 1993
OMNIVIUM PHARMS — Marketing Organization
Aug 12, 1993
Schering-Plough — NDA Secondary Org
Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
Sep 22, 1998
Alkermes — Marketing Organization
Oct 30, 1998
Actavis — Marketing Organization
Oct 30, 1998
Chartwell Pharmaceuticals — Marketing Organization
Oct 7, 1999
SkyePharma AG — Marketing Organization

2000s

Mar 16, 2000
Nesher Pharms — Marketing Organization
Apr 17, 2000
Dexcel Pharma Technologies Ltd. — Marketing Organization
Jun 23, 2005
Arbor Pharmaceuticals — Marketing Organization
Jun 23, 2005
Azurity — NDA Secondary Org
Mar 17, 2008
Impax Laboratories — Marketing Organization

2010s

Aug 11, 2010
Vintage — Marketing Organization
Aug 11, 2010
Strides Pharma Science — Marketing Organization
Jun 3, 2011
Torrent Pharmaceuticals Limited — Marketing Organization
Jan 1, 2012
Earliest Phase 2 Sponsor(trial)
Oct 24, 2017
Accord Research — Marketing Organization
Nov 5, 2018
RiconPharma — Marketing Organization
Nov 20, 2019
Zydus Discovery DMCC — Marketing Organization

2020s

Nov 23, 2021
Bristol-Myers Squibb — Marketing Organization
Apr 29, 2022
Shandong Lanjin Pharmaceuticals Co.,Ltd — Marketing Organization
Jul 8, 2022
Rubicon Research — Marketing Organization
Nov 7, 2022
Aurobindo Pharma — Marketing Organization
Jan 17, 2024
I3 Pharms — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Soluble guanylate cyclaseACTIVATOR
Soluble guanylate cyclase activator
Heterodimer, beta (1 or 2) is binding site
- Soluble guanylate cyclase alpha1/beta1 complex
Unspecified targetOTHER
Osmotic agent
Unspecified targetOTHER
Unknown

Combination products

bidil
with hydralazine

Approval history

approvedPriority reviewNov 9, 1959

Chemistry & pharmacology

Loading structure…

SMILES

O[C@@H]1CO[C@H]2[C@@H]1OC[C@@H]2O

Mol. weight: 146.14 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Discontinued

Oral

Yes

Parenteral

Topical

Sources

Also known as

1,4:3,6-dianhydrosorbitol 2,5-dinitrate
1,4:3,6-dianhydrosorbitol 2,5-dinitrate
5-ismn
5-ismn durules
ahr-4698
ahr-4698
angeze 10
angeze 20
angeze 40
angeze sr 40
angeze sr 60
angitak
angitate
astridine
astrodur mr
at 101
at-101
at-101
at-101
bm 22.145
bm 22.145
bm-22-145
bm-22-145
carmil xl
carvasin
carvasin
carvasin
cedocard
cedocard
cedocard-10
cedocard-20
cedocard-40
cedocard-5
cedocard ret
chemydur 60 xl
cibral 10
cibral 20
cibral 40
cibral xl 60
dianhydrosorbitol 2,5-dinitrate
dianhydrosorbitol 2,5-dinitrate
dilatrate
dilatrate
dilatrate-sr
dilatrate-sr
dinitrate d'isosorbide
dinitrate d'isosorbide
dinitrate isosorbide
dinitrato de isosorbida
dinitrato de isosorbida
dinitroisosorbide
dinitroisosorbide
dinitrosorbide
dinitrosorbide
(+)-d-isosorbide
d-isosorbide dinitrate
d-isosorbide dinitrate
dynamin
dynamin
dynamin xl 25
dynamin xl 50
elantan
elantan
elantan
elantan 10
elantan 20
elantan 40
elantan la 25
elantan la 50
eumon 40 xl
eumon 60 xl
flindix
flindix
imdur
imdur
imdur
imdur
imo la
imtack
is 5-mn
is 5-mn
is-5mn
is-5mn
is-5-mn
is-5-mn
is-5-mn
isdn
isdn
isib 20
isib 40
isib 50 xl
isib 60 xl
ismn
ismn
ismn
ismo
ismo
ismo
ismo 10
ismo 20
ismo 20
ismo 40
ismo ret
ismotic
ismotic
iso-5-mononitrate
iso-5-mononitrate
iso-5-mononitrate
isobide
isocard
isodur
isodur
isodur 25 xl
isodur 50 xl
isoket 0.05%
isoket 0.1%
isoket 10
isoket 20
isoket 5
isoket ret 20
isoket ret 40
iso mack
iso mack
isorbid
isorbid
isordil
isordil
isordil
isordil tembids
isordil tembids
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide
isosorbide 2,5-dinitrate
isosorbide 2,5-dinitrate
isosorbide 5 mononitrate
isosorbide 5 mononitrate
isosorbide 5-mononitrate
isosorbide 5-mononitrate
isosorbide 5-mononitrate
isosorbide-5-mononitrate
isosorbide-5-mononitrate
isosorbide-5-mononitrate
isosorbide-5-mononitrate
isosorbide-5-mononitrate
isosorbide 5-nitrate
isosorbide 5-nitrate
isosorbide 5-nitrate
isosorbide-5-nitrate
isosorbidedinitrate
isosorbidedinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide dinitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbide mononitrate
isosorbidi dinitras
isosorbidi dinitras
isosorbidi mononitras
isosorbidi mononitras
isotard 25 xl
isotard 40 xl
isotard 50 xl
isotard 60 xl
isotrate
isotrate
jeridin
ketanodur
mcr 50
modisal 40 xl
modisal 60 xl
modisal la 25
modisal la 50
monigen xl 60
monit
monit
monit ls
monit sr
monit xl 60
monizid
mono-cedocard 10
mono-cedocard 20
mono-cedocard 40
monocinque
monodur
monodur
monoket
monoket
monoket
mono mac 50d
monomax sr 40
monomax sr 60
monomax xl
monomil xl
mononit
mononitrate d'isosorbide
mononitrate d'isosorbide
mononitrato de isosorbida
mononitrato de isosorbida
monosorbitrate
monosorbitrate
monosorbitrate
monosorb xl 60
monosorb xl 60
nitrosorbide
nitrosorbide
olicard 40
olicard-retard
pertil ret
phasonit la 50
relosorb xl
r-isosorbide dinitrate
r-isosorbide dinitrate
r-isosorbide dinitrate
r-isosorbide dinitrate
r-isosorbide dinitrate
r-isosorbide dinitrate
slomon xl 60
soni-slo
sorbichew
sorbid-20 sa
sorbid-40 sa
sorbide nitrate
sorbide nitrate
sorbide nitrate
sorbidilat
sorbidilat
sorbidilat
sorbidnitrate
sorbidnitrate
sorbid sa
sorbitrate
sorbitrate
tardisc xl
tenkosorb
trangina xl
vascardin
vascardin
vascardin
vasotrate 60 sr
xismox xl 60
zemon 40 xl
zemon 60 xl
ziotan xl

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07252544	Phase 3	Dec 1, 2025	Capital Medical University, China Medical University
NCT06765993	Phase 2/Phase 3 (Phase 3)	Dec 30, 2024	Lunan Better Pharmaceutical Co., LTD.
NCT07121634	N/A	Jan 1, 2024	Al-Mustansiriyah University, University Of Anbar
NCT05276219	Phase 4	Jun 1, 2023	University of Copenhagen
NCT05800938	Phase 4	Jun 8, 2022	Ain Shams University
NCT05341856	Early Phase 1 (Phase 1)	May 1, 2022	Al Azhar University
NCT06400784	Phase 4	Mar 25, 2022	University of Abuja, University of Cambridge
NCT06218199	Phase 4	Jul 8, 2021	Boston Scientific Corporation, Heart Center Research, LLC
NCT04831892	N/A	Apr 7, 2021	Integrative Skin Science and Research, Sytheon Ltd.
NCT04981457	Phase 1	Mar 2, 2021	Cairo University
NCT04729088	Phase 1	Dec 20, 2020	Biolab Sanus Farmaceutica, CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
NCT04482881	Early Phase 1 (Phase 1)	Jul 21, 2020	Aljazeera Hospital, Suez Canal University
NCT04425993	N/A	Jul 1, 2020	People's Liberation Army of China
NCT04310995	Phase 4	May 31, 2020	Chugai, Jiao Tong University
NCT04311658	Phase 3	Mar 30, 2020	Cairo University
NCT04312048	Phase 3	Mar 25, 2020	Cairo University
NCT04297241	Phase 2	Dec 12, 2019	University of Cincinnati
NCT04217668	N/A	Dec 2, 2019	University of Copenhagen
NCT04206865	Phase 4	Nov 25, 2019	The Cleveland Clinic
NCT04218760	N/A	Oct 10, 2019	University of Copenhagen

Showing 20 of 84 trials

Page 1 / 5

Organizations

Research & Development (107)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Cairo University	Academic/Hospital	7	7	3	2015
Ain Shams University	Academic/Hospital	4	4	2	2017
China Academy of Chinese Medical Sciences	Academic/Hospital	4	4	1	2012
Merck	For profit	4	3	1	2006
University of Copenhagen	Academic/Hospital	4	4	2	2015
Harvard University	Academic/Hospital	3	1	3	1990
National Heart, Lung, and Blood Institute (NHLBI)	Government	3	1	3	1990
Arbor Pharmaceuticals	For profit	2	2	1	2012
Assiut University	Academic/Hospital	2	2	2	2015
Biolab Sanus Farmaceutica	For profit	2	2	1	2017
Department of Veteran Affairs	Government	2	2	1	2012
National Institutes of Health (NIH)	Government	2	0	2	1997
People's Liberation Army of China	Government	2	2	1	2016
Sytheon Ltd.	For profit	2	1	2	2017
Torrent Pharmaceuticals Limited	For profit	2	2	1	2011
University of Edinburgh	Academic/Hospital	2	2	2	2015
University of Nottingham	Academic/Hospital	2	0	2	2015
University of Pennsylvania	Academic/Hospital	2	0	1	2012
Vanderbilt University	Academic/Hospital	2	1	2	1997
Al Azhar University	Academic/Hospital	1	1	1	2022

107 organizations

Page 1 / 6

Marketing (56)

Organization	Org type	Relationship	Date
Accord Research	For profit	MKTG	Oct 24, 2017
Actavis	For profit	MKTG	Oct 30, 1998
Alcon	For profit	NDA2	Jan 30, 1974
Alkermes	For profit	MKTG	Sep 22, 1998
American Home Products	For profit	NDA2	Dec 12, 1980
American Home Products	For profit	NDA	Nov 9, 1959
Ani Pharmaceuticals	For profit	MKTG	Jul 20, 1982
Ani Pharmaceuticals	For profit	SYN	Jul 20, 1982
Arbor Pharmaceuticals	For profit	MKTG	Jun 23, 2005
AstraZeneca	For profit	NDA2	Jan 16, 1968
AstraZeneca	For profit	MKTG	—
Aurobindo Pharma	For profit	MKTG	Nov 7, 2022
Auxillium	For profit	NDA2	Sep 2, 1988
Azurity	For profit	NDA2	Jun 23, 2005
Bausch Health Companies	For profit	NDA2	Nov 9, 1959
Bausch Health Companies	For profit	SYN	Nov 9, 1959
Biovail	For profit	NDA2	Dec 20, 1961
Bristol-Myers Squibb	For profit	MKTG	Nov 23, 2021
Chartwell Pharmaceuticals	For profit	MKTG	Oct 30, 1998
Dexcel Pharma Technologies Ltd.	For profit	MKTG	Apr 17, 2000
Dr. Reddy's Laboratories	For profit	NDA2	Dec 30, 1991
Eci Pharmaceuticals Llc	For profit	MKTG	Jun 30, 1993
Eci Pharmaceuticals Llc	For profit	NDA2	Jun 30, 1993
Endo Pharmaceuticals	For profit	MKTG	Sep 28, 1982
Genus Oncology, LLC	For profit	MKTG	Jun 30, 1993
Genus Oncology, LLC	For profit	SYN	Oct 30, 1998
Hikma	For profit	MKTG	Mar 9, 1982
Hikma	For profit	SYN	Jan 7, 2005
Hikma	For profit	SYN	Oct 5, 2000
Hikma	For profit	SYN	Oct 5, 2000
I3 Pharms	For profit	MKTG	Jan 17, 2024
Impax Laboratories	For profit	MKTG	Mar 17, 2008
Lannett Company, Inc.	For profit	NDA2	Jun 30, 1993
Nesher Pharms	For profit	MKTG	Mar 16, 2000
OMNIVIUM PHARMS	For profit	MKTG	Jun 30, 1993
Par Pharmaceuticals	For profit	MKTG	Sep 28, 1982
Par Pharmaceuticals	For profit	SYN	Nov 23, 2021
RiconPharma	For profit	MKTG	Nov 5, 2018
Rubicon Research	For profit	MKTG	Jul 8, 2022
Sandoz	For profit	MKTG	Apr 28, 1982
Schering-Plough	For profit	NDA2	Aug 12, 1993
Shandong Lanjin Pharmaceuticals Co.,Ltd	For profit	MKTG	Apr 29, 2022
SkyePharma AG	For profit	MKTG	Oct 7, 1999
Strides Pharma Science	For profit	MKTG	Aug 11, 2010
Sun Pharmaceuticals	For profit	SYN	Dec 30, 1998
Sun Pharmaceuticals	For profit	MKTG	Dec 1, 1978
Superpharm	For profit	MKTG	Feb 17, 1987
Teva	For profit	MKTG	Feb 25, 1985
Teva	For profit	SYN	Jun 19, 2000
Torrent Pharmaceuticals Limited	For profit	MKTG	Jun 3, 2011
Vintage	For profit	MKTG	Aug 11, 2010
Watson Pharmaceuticals	For profit	MKTG	Jul 20, 1982
Zydus Discovery DMCC	For profit	SYN	Mar 16, 2000
Zydus Discovery DMCC	For profit	MKTG	Nov 20, 2019
Zydus Discovery DMCC	For profit	SYN	Mar 16, 2000
Zydus Discovery DMCC	For profit	SYN	Nov 20, 2019