phendimetrazine

Trade name: plegine

Small moleculeapproved

Approved

Jun 1, 1961

Phendimetrazine is an appetite suppressant that is FDA approved for the treatment of exogenous obesity. It is clinically available anorectic agent, which display minimal interactions with monoamine transporters in vitro. On the other hand, their medications is known to be psychomotor stimulants when administered in vivo as indicated by their shared properties with illicit drugs like cocaine. The following adverse reactions are described, or described in greater detail, in other sections: Primary pulmonary hypertension; Valvular heart disease; Effect on the ability to engage in potentially hazardous tasks; Withdrawal effects following prolonged high dosage administration. Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. — NCATS

Clinical trial activity

4 trials · 6 clinical orgs · 29 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Aug 1, 2013 (NCT01934036)

Timeline

1960s

Jun 1, 1961
American Home Products — Earliest FDA Approval
Jun 1, 1961
American Home Products — NDA Organization

1970s

Oct 20, 1975
Numark — Marketing Organization
Jul 22, 1976
Teva — Marketing Organization
Jul 28, 1976
Chartwell Pharmaceuticals — Marketing Organization
Sep 29, 1976
Ferndale Laboratories, Inc. — Marketing Organization
Dec 22, 1976
Bausch Health Companies — Marketing Organization
Jan 11, 1977
Barr Laboratories — Marketing Organization
May 6, 1977
AmerisourceBergen — Marketing Organization
May 9, 1977
Mylan — Marketing Organization
May 11, 1977
Camall Co, Inc. — Marketing Organization
May 11, 1977
Ivax — Marketing Organization
Jun 2, 1977
Lumara Health — Marketing Organization
Aug 19, 1977
Virtus Pharms — NDA Secondary Org
Aug 19, 1977
Virtus Pharms — Marketing Organization
Nov 28, 1977
Watson Pharmaceuticals — Marketing Organization
Feb 28, 1978
Nexgen Pharma, Inc — Marketing Organization
Apr 19, 1978
Sandoz — Marketing Organization

1980s

May 28, 1981
Upsher-Smith Laboratories — Marketing Organization
Sep 16, 1981
Shire — Marketing Organization
May 19, 1982
Vitarine — Marketing Organization
Aug 16, 1982
Graham Dm — Marketing Organization

1990s

Oct 30, 1991
Mikart — Marketing Organization

2000s

Jan 28, 2008
Elite Laboratories, Inc — Marketing Organization

2010s

Aug 31, 2010
Kvk Tech Inc — Marketing Organization
Jan 1, 2013
Earliest Phase 2 Sponsor(trial)
Jan 1, 2015
Earliest Phase 1 Sponsor(trial)
Dec 27, 2017
Nostrum Laboratories — Marketing Organization
Jan 1, 2018
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Obesity (approved 1979)

Studied for

Mechanism of action

Dopamine transporterINHIBITOR
SLC6A3 inhibitor
- Sodium-dependent dopamine transporter (SLC6A3) ↗
Norepinephrine transporterINHIBITOR
SLC6A2 inhibitor
- Sodium-dependent noradrenaline transporter (SLC6A2) ↗

Approval history

approvedJun 1, 1961

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1[C@H](c2ccccc2)OCCN1C

Mol. weight: 191.27 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

(2s,3s)-3,4-dimethyl-2-phenylmorpholine
(2s,3s)-3,4-dimethyl-2-phenylmorpholine
adipost
antapentan
bontril
bontril
bontril
di-ap-trol
dyrexan
hyrex
melfiat
mephenmetrazine
obezine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
phendimetrazine
(+)-phendimetrazine
phendimetrazine, (2r-cis)-isomer
phendimetrazine, (2s-trans)-isomer
phendimetrazine hcl
phendimetrazine hydrochloride
phendimetrazine hydrochloride
phendimetrazine hydrochloride
phendimetrazine hydrochloride
phendimetrazine hydrochloride
phendimetrazine hydrochloride
phendimetrazine hydrochloride, (2s-trans)-isomer
phendimetrazine tartrate
phendimetrazine tartrate
phendimetrazine tartrate
phendimetrazine tartrate
phendimetrazine tartrate
phendimetrazine tartrate
phendimetrazine tartrate, (2s-trans(r-(r*,r*)))-isomer
phendimetrazine tartrate, (r-(r*,r*))-isomer
phendimetrazine, trans(+-)-isomer
plegine
plegine
plegine
prelu-2
sedafamen
trimstat
wehless
weightrol
x-trozine
x-trozine
x-trozine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT03541005	Phase 3	Oct 1, 2018	Catalysis SL, National Coordinator Center of Clinical Trials (CENCEC)
NCT02522325	Phase 1	Aug 1, 2015	National Institute on Drug Abuse (NIDA), University of Kentucky
NCT02145442	Phase 2/Phase 3 (Phase 3)	Jun 1, 2014	Catalysis SL, National Institute of Endocrinology, Havana, Cuba
NCT01934036	Phase 2/Phase 3 (Phase 3)	Aug 1, 2013	Catalysis SL, Universidad Autonoma de Madrid

Showing 4 of 4 trials

Page 1 / 1

Organizations

Research & Development (6)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Catalysis SL	For profit	3	3	1	2013
National Coordinator Center of Clinical Trials (CENCEC)	Academic/Hospital	1	0	1	2018
National Institute of Endocrinology, Havana, Cuba	Academic/Hospital	1	0	1	2014
National Institute on Drug Abuse (NIDA)	Government	1	0	1	2015
Universidad Autonoma de Madrid	Academic/Hospital	1	0	1	2013
University of Kentucky	Academic/Hospital	1	1	1	2015

6 organizations

Page 1 / 1

Marketing (33)

Organization	Org type	Relationship	Date
American Home Products	For profit	NDA	Jun 1, 1961
AmerisourceBergen	For profit	MKTG	May 6, 1977
Barr Laboratories	For profit	MKTG	Jan 11, 1977
Bausch Health Companies	For profit	MKTG	Dec 22, 1976
Camall Co, Inc.	For profit	MKTG	May 11, 1977
Chartwell Pharmaceuticals	For profit	SYN	Oct 30, 1991
Chartwell Pharmaceuticals	For profit	MKTG	Jul 28, 1976
Elite Laboratories, Inc	For profit	MKTG	Jan 28, 2008
Ferndale Laboratories, Inc.	For profit	MKTG	Sep 29, 1976
Forest Laboratories	For profit	MKTG	—
Graham Dm	For profit	MKTG	Aug 16, 1982
Inwood Laboratories	For profit	MKTG	—
Ivax	For profit	MKTG	May 11, 1977
Kvk Tech Inc	For profit	MKTG	Aug 31, 2010
Lumara Health	For profit	MKTG	Jun 2, 1977
MFG CHEMISTS	For profit	MKTG	—
MM Pharma	For profit	MKTG	—
Mikart	For profit	MKTG	Oct 30, 1991
Mylan	For profit	MKTG	May 9, 1977
Nexgen Pharma, Inc	For profit	MKTG	Feb 28, 1978
Nostrum Laboratories	For profit	MKTG	Dec 27, 2017
Numark	For profit	MKTG	Oct 20, 1975
Sandoz	For profit	MKTG	Apr 19, 1978
Shire	For profit	MKTG	Sep 16, 1981
Solvay	For profit	MKTG	—
Teva	For profit	MKTG	Jul 22, 1976
Teva	For profit	SYN	Dec 16, 1977
Upsher-Smith Laboratories	For profit	MKTG	May 28, 1981
Upsher-Smith Laboratories	For profit	SYN	May 28, 1981
Virtus Pharms	For profit	NDA2	Aug 19, 1977
Virtus Pharms	For profit	MKTG	Aug 19, 1977
Vitarine	For profit	MKTG	May 19, 1982
Watson Pharmaceuticals	For profit	MKTG	Nov 28, 1977