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Late-Stage Obesity Pipeline Is Stuffed With Mix Of Mechanisms

This article was originally published in Pharmaceutical Approvals Monthly

Following the rejection of three late-stage obesity candidates, there is uncertainty for drugs remaining in the pipeline. In particular, regulatory scrutiny is expected to be intense for drugs that have potential for cardiovascular and/or psychiatric effects. Sources: Inteleos, company websites.

Drug name/Sponsor

Mechanism of action

NDA Submitted, Received “Complete Response” Letter From FDA

Qnexa (phentermine/topiramate)/Vivus

Appetite suppressant/anticonvulsant

Contrave (buproprion SR/naltrexone SR)/Orexigen and Takeda

Proprietary combination formulation of approved antidepressant and approved opioid inhibitor

Lorcaserin/Arena and Eisai

Selective serotonin 2C receptor antagonist

Phase III

Victoza (liraglutide)/Novo Nordisk

Glucagon-like peptide 1 analog approved for diabetes

Cetilistat/Takeda (Norgine holds rights)

Lipase inhibitor

Phase II

Empatic (zonisamide/buproprion SR)/Orexigen

Proprietary combination of zonisamide, a sulfonamide anticonvulsant approved for epilepsy, and buproprion

BMS830216/Bristol-Myers Squibb

Melonin concentrating hormone receptor 1 antagonist

Canagliflozin/Johnson & Johnson and Mitsubishi Tanabe Pharma

Sodium glucose co-transporter 2 inhibitor, also being tested in diabetes

GSK1521498/GlaxoSmithKline

Mu-opioid inverse receptor antagonist

Velneperit (S-2367)/Shionogi

Neuropeptide Y receptor Y5 antagonist

Tesofensine/NeuroSearch

Acetylcholine release enhancer; noradrenaline reuptake inhibitor; dopamine reuptake inhibitor; serotonin reuptake inhibitor

TTP-435/Transtech

Selective inhibitor of agouti related protein

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