Overview
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Research Report
Comprehensive Clinical Development Review: Lotiglipron (PF-07081532)
1. Introduction to Lotiglipron (PF-07081532)
Lotiglipron, identified by the code PF-07081532, was an investigational, orally administered, small-molecule therapeutic agent developed by Pfizer Inc..[1] It belongs to the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class of drugs.[3] The intended therapeutic indications for lotiglipron were the management of Type 2 Diabetes Mellitus (T2D) and obesity.[1]
The development of lotiglipron represented an effort to provide a convenient oral alternative to the widely successful injectable peptide-based GLP-1 RAs, such as semaglutide and liraglutide, which dominate the treatment landscape for T2D and obesity.[2] Pfizer pursued the development of lotiglipron concurrently with another oral small-molecule GLP-1 RA, danuglipron (PF-06882961).[1] This parallel development strategy suggested a high perceived value in capturing a share of the oral metabolic drug market, while also acknowledging the inherent risks and challenges in bringing such a novel small-molecule agent through clinical trials successfully. Despite initial promise, the clinical development of lotiglipron was ultimately discontinued by Pfizer in June 2023 due to safety concerns.[1]
2. Mechanism of Action and Therapeutic Rationale
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/28 | Phase 1 | Terminated | |||
2023/02/27 | Phase 1 | Completed | |||
2023/01/05 | Phase 1 | Terminated | |||
2022/10/14 | Phase 2 | Terminated | |||
2022/08/22 | Phase 1 | Terminated | |||
2022/07/28 | Phase 1 | Completed | |||
2021/12/15 | Phase 1 | Completed | |||
2020/03/12 | Phase 1 | Completed | |||
2019/11/01 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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