Overview
Phentermine is a sympathomimetic amine anorectic agent and it was introduced in 1959 as part of an anti-obesity combination drug. It is chemically related to amphetamine and it is commonly referred to as an atypical amphetamine. Phentermine has not been reported an addictive potential which allows this agent to be classified under the Schedule IV drugs (low abuse potential). Phentermine was FDA approved for short-term weight management in 1959 and it became widely used in 1960. This initial product, formed by the combination of phentermine with fenfluramine and dexfenfluramine was discontinued after finding several reports of abnormal valves in nearly 30% of the consumers. Later on, phentermine was approved alone and in combination with topiramate in 2012 as a new alternative that required lower doses of phentermine to obtain the desired effect.
Indication
Phentermine is indicated, alone or in combination with topiramate, as a short-term adjunct, not pass a few weeks, in a regimen of weight reduction based on exercise, behavioral modifications and caloric restriction in the management of exogenous obesity for patients with an initial body mass index (BMI) greater than 30 kg/m2 or greater than 27 kg/m2 in presence of other risk factors such as controller hypertension, diabetes or hyperlipidemia. Exogenous obesity is considered when the overweight is caused by consuming more food than the person activity level warrants. This condition commonly causes an increase in fat storage. It is an epidemic condition in the United States where over two-thirds of adults are overweight or obese and one in three Americans is obese. In the world, the incidence of obesity has nearly doubled.
Associated Conditions
- Obesity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/08 | Phase 2 | Recruiting | |||
2023/08/04 | Phase 4 | Recruiting | |||
2023/03/06 | N/A | Active, not recruiting | |||
2022/01/31 | Phase 4 | Completed | |||
2022/01/04 | Phase 4 | Active, not recruiting | |||
2020/11/09 | Phase 3 | Completed | |||
2020/11/04 | Phase 4 | Completed | |||
2020/10/01 | Phase 2 | Withdrawn | Janey Pratt | ||
2020/08/28 | Phase 4 | Terminated | |||
2019/09/19 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lannett Company, Inc. | 0527-1398 | ORAL | 15 mg in 1 1 | 4/7/2017 | |
| Lannett Company, Inc. | 0527-1366 | ORAL | 30 mg in 1 1 | 4/7/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUROMINE CAPSULE 15 mg | SIN01255P | CAPSULE | 15 mg | 5/16/1988 | |
| DUROMINE CAPSULE 30 mg | SIN01256P | CAPSULE | 30 mg | 5/16/1988 | |
| PANBESY CAPSULE 30 mg | SIN05113P | CAPSULE | 30 mg | 10/9/1990 | |
| PANBESY CAPSULE 15 MG | SIN05315P | CAPSULE | 15 mg | 1/7/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DUROMINE CAP 30MG | N/A | N/A | N/A | 7/28/1983 | |
| DUROMINE CAP 15MG | N/A | N/A | N/A | 7/28/1983 | |
| DUROMINE CAP 40MG CONTROLLED RELEASE | N/A | N/A | N/A | 5/19/1987 |
TGA Drug Approvals
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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