phentermine
Trade name: wyamine
Approved
May 4, 1959
Phentermine is an amphetamine that stimulates neurons to release or maintain high levels of a particular group of neurotransmitters known as catecholamines; these include dopamine and norepinephrine. High levels of these catecholamines tend to suppress hunger signals and appetite. The drug seems to inhibit reuptake of noradrenaline, dopamine, and seratonin through inhibition or reversal of the reuptake transporters. It may also inhibit MAO enzymes leaving more neurotransmitter available at the synapse. Phentermine (through catecholamine elevation) may also indirectly affect leptin levels in the brain. It is theorized that phentermine can raise levels of leptin which signal satiety. It is also theorized that increased levels of the catecholamines are partially responsible for halting another chemical messenger known as neuropeptide Y. This peptide initiates eating, decreases energy expenditure, and increases fat storage. Phentermine is indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction. Phentermine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. — NCATS
Clinical trial activity
63 trials · 56 clinical orgs · 37 marketing orgs
Earliest trial started May 1, 1983 (NCT00000506)
Timeline
1950s
- Dec 29, 1951
American Home Products — First NDA Organization
- Dec 29, 1951
American Home Products — NDA Organization
- May 4, 1959
Earliest FDA Approval
- May 4, 1959
UCB — NDA Secondary Org
1970s
- Aug 14, 1973
GlaxoSmithKline — NDA Secondary Org
- Feb 24, 1976
Solvay — Marketing Organization
- Jul 1, 1976
Chartwell Pharmaceuticals — Marketing Organization
- Apr 11, 1978
Ivax — Marketing Organization
- May 19, 1978
Watson Pharmaceuticals — Marketing Organization
1980s
- Mar 24, 1980
MM Pharma — Marketing Organization
- Sep 10, 1980
AmerisourceBergen — Marketing Organization
- Sep 10, 1980
Camall Co, Inc. — Marketing Organization
- Oct 22, 1980
Teva — Marketing Organization
- Apr 14, 1981
Ferndale Laboratories, Inc. — Marketing Organization
- Feb 3, 1982
Vitarine — Marketing Organization
- Mar 18, 1982
Shire — Marketing Organization
- Apr 9, 1982
Upsher-Smith Laboratories — Marketing Organization
- Jan 1, 1983
Earliest Phase 2 Sponsor(trial)
- Apr 25, 1986
Duramed Research — Marketing Organization
- Sep 28, 1987
Sandoz — Marketing Organization
1990s
- Mar 7, 1997
Tg United Inc — Marketing Organization
- May 30, 1997
Elite Laboratories, Inc — Marketing Organization
- Nov 25, 1998
Actavis — Marketing Organization
2000s
- Aug 30, 2001
Able Laboratories — Marketing Organization
- Jan 4, 2002
Prinston Inc — Marketing Organization
- Oct 23, 2003
Sun Pharmaceuticals — Marketing Organization
- Jan 1, 2007
- Jan 1, 2007
- Aug 31, 2009
Barr Laboratories — Marketing Organization
2010s
- Jul 16, 2010
Lannett Company, Inc. — Marketing Organization
- Jun 13, 2011
Citius Pharmaceuticals — NDA Secondary Org
- Jul 17, 2012
Vivus — Marketing Organization
- Jul 17, 2012
Vivus — NDA Secondary Org
- Sep 21, 2012
Novast Labs — Marketing Organization
- Feb 5, 2014
Invagen Pharms — Marketing Organization
- Aug 6, 2014
Aurobindo Pharma — Marketing Organization
- Sep 25, 2014
Nuvo Research Inc. — Marketing Organization
- Sep 12, 2016
Avanthi Pharma — Marketing Organization
- Nov 18, 2016
Dalian Merro Pharmaceutical Co. Ltd — Marketing Organization
- Nov 18, 2016
Polygen Pharmaceuticals — Marketing Organization
- Mar 17, 2017
Kvk Tech Inc — Marketing Organization
- Jun 28, 2017
Zydus Discovery DMCC — Marketing Organization
Indications
Studied for
- Adolescent · Phase 2
- Bariatric Surgery · Phase 4
- Binge-Eating Disorder · Phase 2
- Bipolar Disorder · Phase 4
- Blood Pressure · Phase 4
- Body Weight · Phase 4
- Bulimia Nervosa · Phase 1
- Cocaine-Related Disorders · Phase 1
- Colitis, Ulcerative · Phase 2
- Craniopharyngioma · Phase 2
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 4
- Drug Therapy · Phase 2
- Glucagon-Like Peptide 1 · Phase 4
- Gout · Phase 3
- Healthy Lifestyle · Phase 4
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 2
- Hypertension · Early Phase 1
- Hypothalamic Neoplasms · Phase 2
- Kidney Failure, Chronic · Phase 1
- Liver Diseases · Phase 1
- Non-alcoholic Fatty Liver Disease · Phase 4
- Obesity, Morbid · Phase 4
- Overweight · Phase 2
- Parkinson Disease · Phase 1
- Pediatric Obesity · Phase 4
- Polycystic Ovary Syndrome · Phase 3
- Prediabetic State · Phase 3
- Schizophrenia · Phase 4
- Sleep Apnea Syndromes · Phase 1/Phase 2
- Substance-Related Disorders · Phase 1
- Torsades de Pointes · Phase 1
- Vascular Diseases · Phase 2
- Weight Loss · Phase 4
- Young Adult · Phase 2
Mechanism of action
- Norepinephrine transporterRELEASING AGENT
SLC6A2 releasing agent
Combination products
qsymia
with topiramate
Also known as phentermine/topiramate (qsymia)
Approval history
- approvedPriority reviewMay 4, 1959
Chemistry & pharmacology
SMILES
CC(C)(N)Cc1ccccc1- Mol. weight
- 149.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1574 ↗
- WikipediaPhentermine ↗
- NCATSC045TQL4WP ↗
- ChEMBLCHEMBL1200912 ↗
Also known as
- alpha,alpha-dimethylphenethylamine
- alpha,alpha-dimethylphenethylamine
- duromine
- duromine
- duromine
- fentermina
- fentermina
- ionamin
- ionamin
- ionamin
- normephentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine
- phentermine hcl
- phentermine hcl
- phentermine hcl
- phentermine hydrochloride
- phentermine hydrochloride
- phentermine hydrochloride
- phentermine hydrochloride
- phentermine mixture with topiramate
- phentermine resin
- phentermine resin
- phentermine resin 30
- phentermine resin 30
- phentermine resin complex
- phentermine resin complex
- phentermine resin complex
- phentermine resin complex
- phentermine / topiramate
- phenterminum
- phenterminum
- vi-0521
- vi-0521
- wilpo
- wilpo
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07282340 | Phase 2 | Dec 31, 2025 | Heartland DCOC, IDeA States Pediatric Clinical Trials Network, National Institutes of Health (NIH) |
| NCT07213466 | Phase 4 | Dec 1, 2025 | Mayo Clinic, University of Toronto |
| NCT06768320 | Phase 4 | Mar 31, 2025 | Loma Linda University |
| NCT06854614 | Phase 4 | Mar 1, 2025 | The Cleveland Clinic |
| NCT06299891 | Phase 2 | Aug 1, 2024 | University of Pennsylvania, University of Washington |
| NCT05834062 | Phase 2 | Oct 17, 2023 | University of Minnesota |
| NCT05975580 | Phase 4 | Aug 29, 2023 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Irvine |
| NCT05579249 | Phase 4 | Jan 20, 2023 | Novo Nordisk |
| NCT05176626 | Phase 4 | Jun 30, 2022 | Biomedical Research Institute of New Mexico, HealthPartners Institute, Johns Hopkins University, Kaiser Permanente, Kvk Tech Inc, National Heart, Lung, and Blood Institute (NHLBI), University of Texas at Houston, Wake Forest University, Weight Watchers International |
| NCT04881799 | Early Phase 1 (Phase 1) | Feb 1, 2022 | University of Minnesota |
| NCT05215418 | Phase 4 | Jan 25, 2022 | Vivus |
| NCT05378503 | Phase 4 | Sep 17, 2021 | Alvogen, Hanyang University |
| NCT04693039 | Phase 1 | Jan 31, 2021 | Capital Medical University, Yiling Pharmaceutical Inc. |
| NCT04614545 | Phase 4 | Jan 1, 2021 | The Cleveland Clinic |
| NCT04621929 | Phase 3 | Jan 1, 2021 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida |
| NCT04572217 | Phase 2 | Dec 31, 2020 | Stanford University |
| NCT04721873 | Phase 2 | Dec 18, 2020 | University of California, San Diego |
| NCT04531176 | Phase 4 | Sep 1, 2020 | The Cleveland Clinic |
| NCT04408586 | Phase 4 | Jun 1, 2020 | Mayo Clinic |
| NCT04298203 | Phase 2 | Apr 30, 2020 | University of Minnesota |
Organizations
Research & Development (56)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Vivus | For profit | 18 | 17 | 5 | 2007 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 5 | 0 | 3 | 2013 |
| AstraZeneca | For profit | 4 | 2 | 4 | 2006 |
| Mayo Clinic | Academic/Hospital | 4 | 4 | 2 | 2013 |
| Medpace, Inc. | For profit | 4 | 0 | 1 | 2007 |
| University of Minnesota | Academic/Hospital | 4 | 4 | 2 | 2019 |
| Duke University | Academic/Hospital | 3 | 0 | 1 | 2007 |
| Sentrx | For profit | 3 | 0 | 2 | 2008 |
| Synteract, Inc. | For profit | 3 | 0 | 1 | 2007 |
| The Cleveland Clinic | Academic/Hospital | 3 | 3 | 1 | 2020 |
| Yiling Pharmaceutical Inc. | For profit | 3 | 3 | 1 | 2017 |
| INC Research | For profit | 2 | 0 | 1 | 2012 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 2 | 1 | 2 | 1983 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 1 | 2019 |
| Novo Nordisk | For profit | 2 | 2 | 1 | 2019 |
| Stanford University | Academic/Hospital | 2 | 2 | 2 | 2015 |
| University of Florida | Academic/Hospital | 2 | 2 | 2 | 2009 |
| University of Pennsylvania | Academic/Hospital | 2 | 1 | 2 | 2019 |
| Wake Forest University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| Alvogen | For profit | 1 | 1 | 1 | 2021 |
Marketing (44)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Able Laboratories | For profit | MKTG | Aug 30, 2001 |
| Actavis | For profit | MKTG | Nov 25, 1998 |
| American Home Products | For profit | NDA | Dec 29, 1951 |
| AmerisourceBergen | For profit | MKTG | Sep 10, 1980 |
| Aurobindo Pharma | For profit | MKTG | Aug 6, 2014 |
| Avanthi Pharma | For profit | MKTG | Sep 12, 2016 |
| Barr Laboratories | For profit | MKTG | Aug 31, 2009 |
| Camall Co, Inc. | For profit | MKTG | Sep 10, 1980 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 1, 1976 |
| Citius Pharmaceuticals | For profit | NDA2 | Jun 13, 2011 |
| Dalian Merro Pharmaceutical Co. Ltd | For profit | MKTG | Nov 18, 2016 |
| Duramed Research | For profit | MKTG | Apr 25, 1986 |
| Elite Laboratories, Inc | For profit | SYN | Jan 31, 2011 |
| Elite Laboratories, Inc | For profit | MKTG | May 30, 1997 |
| Ferndale Laboratories, Inc. | For profit | MKTG | Apr 14, 1981 |
| GlaxoSmithKline | For profit | NDA2 | Aug 14, 1973 |
| Invagen Pharms | For profit | MKTG | Feb 5, 2014 |
| Ivax | For profit | MKTG | Apr 11, 1978 |
| Kvk Tech Inc | For profit | SYN | Mar 21, 2008 |
| Kvk Tech Inc | For profit | MKTG | Mar 17, 2017 |
| Lannett Company, Inc. | For profit | SYN | Feb 3, 1983 |
| Lannett Company, Inc. | For profit | MKTG | Jul 16, 2010 |
| MM Pharma | For profit | MKTG | Mar 24, 1980 |
| Novast Labs | For profit | MKTG | Sep 21, 2012 |
| Nuvo Research Inc. | For profit | MKTG | Sep 25, 2014 |
| Polygen Pharmaceuticals | For profit | MKTG | Nov 18, 2016 |
| Prinston Inc | For profit | MKTG | Jan 4, 2002 |
| Quantum Pharmaceutical | For profit | MKTG | — |
| Sandoz | For profit | SYN | Apr 28, 1978 |
| Sandoz | For profit | MKTG | Sep 28, 1987 |
| Sandoz | For profit | NDA2 | — |
| Shire | For profit | MKTG | Mar 18, 1982 |
| Solvay | For profit | MKTG | Feb 24, 1976 |
| Sun Pharmaceuticals | For profit | SYN | Aug 21, 2007 |
| Sun Pharmaceuticals | For profit | MKTG | Oct 23, 2003 |
| Teva | For profit | MKTG | Oct 22, 1980 |
| Tg United Inc | For profit | MKTG | Mar 7, 1997 |
| UCB | For profit | NDA2 | May 4, 1959 |
| Upsher-Smith Laboratories | For profit | MKTG | Apr 9, 1982 |
| Vitarine | For profit | MKTG | Feb 3, 1982 |
| Vivus | For profit | MKTG | Jul 17, 2012 |
| Vivus | For profit | NDA2 | Jul 17, 2012 |
| Watson Pharmaceuticals | For profit | MKTG | May 19, 1978 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 28, 2017 |