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Adipex-P

(Phentermine)

ApprovedSmall molecule

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phentermine is a prescription medication used to help people lose weight by reducing appetite and increasing energy. It's typically prescribed for short-term use (a few weeks to months) as part of a weight loss program for people who are obese or overweight.[2] Adipex-P is currently approved and in use across 5 indications[4].[1]

Adipex-P is one of 159 small molecule programs targeting Kidney Disease. It is currently in Approved.

5

Indications

27

Total Trials

5

Active Trials

158

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

Kidney DiseaseApproved

Diabetes MellitusApproved

Liver DiseaseApproved

Hypothalamic ObesityActive, not recruiting

Acute Lymphoblastic Leukemia in RemissionNot yet recruiting

Kidney DiseaseApproved

Approved

Diabetes MellitusApproved

Approved

Liver DiseaseApproved

Approved

Hypothalamic ObesityPhase 2

Active, not recruiting

Acute Lymphoblastic Leukemia in RemissionPhase 2

Not yet recruiting

Competition

Competitive Landscape

111 competitors in Diabetes Mellitus

#DrugCompanyPhaseTrials

Adipex-P

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Farxiga

Actos

Precose

Tricor

Topamax

Adrenaline

SSamson Clinical Operations Pty Ltd

Nesina

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Zofran

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Hypothalamic Obesity

NCT06299891

Q1 2028

Phase 2Recruiting

Childhood Obesity

NCT07282340

ApprovedRecruiting

Obesity

NCT05975580

Q3 2031

Phase 2Not yet recruiting

Acute Lymphoblastic Leukemia in Remission

NCT07790913

Clinical

Trials by Indication[1]

Obesity5 trials

Anti-obesity Pharmacotherapy and Inflammation

Active, not recruiting·LLouisiana State University Health Sciences Center in New Orleans··NCT05756764·30 enrolled

Cardiovascular System in Obesity: Effect of Treatment

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000506

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

Completed·VVIVUS LLC·Phase 3·NCT00563368·756 enrolled

Show 2 more trials

Individualized Obesity Pharmacotherapy

Completed·MMayo Clinic·Phase 3·NCT03374956·193 enrolled

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

Recruiting·UUniversity of California, Irvine·Approved·NCT05975580·120 enrolled

Overweight4 trials

Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02243202·335 enrolled

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00402077·258 enrolled

A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

Completed·VVIVUS LLC·Phase 4·NCT05215418·565 enrolled

Show 1 more trial

Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity

Completed·TThe Cleveland Clinic·Phase 4·NCT04614545·70 enrolled

Abuse Potential3 trials

Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 1·NCT01500018

Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users

Completed·BBioprojet·Phase 1·NCT03152123·43 enrolled

A Study to Evaluate Abuse Potential of Istradefylline

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 1·NCT02609477·42 enrolled

Bariatric Surgery3 trials

Medications After Adolescent Bariatric Surgery

Withdrawn·JJaney Pratt·Phase 2·NCT04572217

Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Completed·HHospital Juarez de Mexico·Phase 4·NCT03849729·92 enrolled

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04095104·13 enrolled

Weight loss3 trials

The Effect of Phentermine and B12 on Weight Loss Among Obese Patients

Completed·—·Phase 1·NCT01719185·22 enrolled

Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment

Completed·UUniversity of Pennsylvania·Phase 4·NCT03779048·147 enrolled

Phentermine/Gastric Band Weight Loss Study

Withdrawn·WWake Forest University Health Sciences·N/A·NCT00771654

9 more indications

Liraglutide1 trial

Lifestyle Modification and Liraglutide

Completed·UUniversity of Pennsylvania·Phase 4·NCT02911818·150 enrolled

Cocaine Dependence1 trial

Topiramate-Phentermine Combinations for Cocaine Dependence

Completed·UUniversity of Kentucky·Phase 1·NCT02239913·38 enrolled

Caloric Restriction1 trial

Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)

Completed·—·N/A·NCT01616082·39 enrolled

Adult1 trial

Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

Completed·VVIVUS LLC·Phase 1·NCT00518466·64 enrolled

Hypothalamic Obesity1 trial

Phentermine/Topiramate in Children, Adolescents, and Young Adults With Hypothalamic Obesity: a Pilot and Feasibility Study

Active, not recruiting·SSeattle Children's Hospital·Phase 2·NCT06299891·24 enrolled

Obesity & Overweight1 trial

Adaptive Pharmacotherapy in Obesity: Intermittent Phentermine Improves Visceral Adiposity and Body Composition

Completed·OOSCAR MANUEL TORRES FALCON·Approved·NCT07870668·600 enrolled

Childhood Obesity1 trial

Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity

Recruiting·RRussell McCulloh, MD·Phase 2·NCT07282340·240 enrolled

Acute Lymphoblastic Leukemia in Remission1 trial

Obesity Treatment Using Phentermine-Topiramate ER to Improve Metabolic Health in Adolescents and Young Adults Surviving Leukemia and Lymphoma

Not yet recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT07790913·100 enrolled

Unspecified1 trial

Studying the Effects of Phentermine on Eating Behavior

Completed·NNew York State Psychiatric Institute·Phase 4·NCT01886937·13 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

FASTIN

NDA NDA017352

Jan 1, 1982

WILPO

NDA NDA012737

Jun 13, 2011

SUPRENZA

NDA NDA202088

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Phentermine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Adipex-P drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Phentermine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Phentermine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202088). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Adipex-P. U.S. Food & Drug Administration.
[7]
SEC EDGAR — McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Norepinephrine Transporter Releasing Agent[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Patent Landscape[6]

Patent Cliff

Mar 14, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8440170Mar 14, 2029

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