Aug 3, 2026Phase advancementPemvidutide
PERFORMA Phase 3 MASH trial initiated
Altimmune initiated the global PERFORMA registrational Phase 3 trial in MASH, moving pemvidutide into late-stage clinical development for that indication.
Obesity & Metabolic Pipeline
Emerging metabolic drugs: what stage are they actually in?
A source-linked tracker for next-generation obesity and metabolic programs. It separates FDA review from Phase 3, regional approvals from U.S. approval, and indication-specific development so compounds are not flattened into the same “research peptide” bucket. Dated milestone history shows how selected programs reached their current status.
Under U.S. FDA review
1
Regional approval represented
1
Phase 3 / Phase 3 transition
6
Review due
0
Stage labels need context
A compound can be approved in one country and investigational in another, or be in Phase 3 for MASH while its obesity program remains Phase 2-complete. BACToBasics uses the most specific current description we can support instead of assigning one universal status label.
Recent pipeline changes
Latest dated milestones
These are material sourced events, not ordinary verification-date refreshes.
May 6, 2026Phase advancementZenagamtide
AMAZE Phase 3 obesity program initiated
Novo Nordisk reported that the AMAZE Phase 3 program had been initiated, advancing zenagamtide (formerly amycretin) into pivotal obesity development.
Feb 23, 2026Trial readoutCagriSema
REDEFINE 4 head-to-head results reported
Novo Nordisk reported 23% weight loss under the trial efficacy estimand, but CagriSema did not meet the primary non-inferiority endpoint versus tirzepatide in REDEFINE 4.
Dec 18, 2025Regulatory submissionCagriSema
U.S. weight-management NDA submitted
Novo Nordisk submitted a New Drug Application to the FDA for the fixed-dose cagrilintide/semaglutide combination for chronic weight management.
Nov 4, 2025Program statusMariTide
MARITIME-1 and MARITIME-2 Phase 3 enrollment completed
Amgen reported completed enrollment in its two core chronic-weight-management Phase 3 trials while additional cardiovascular, heart-failure, and sleep-apnea studies continued.
Jun 27, 2025ApprovalMazdutide
China NMPA approved mazdutide for chronic weight management
China's NMPA approved mazdutide for chronic weight management, making the program regionally approved while it remained unapproved by the U.S. FDA.
Novo Nordisk
CagriSema
Mechanism
Fixed-dose cagrilintide + semaglutide combination targeting amylin and GLP-1 pathways.
Modality
Fixed-dose peptide combination
Regulatory context
Investigational in the United States. Novo Nordisk submitted the weight-management NDA to the FDA in December 2025 and has said a U.S. decision is expected in Q4 2026.
Current program
The REDEFINE and REIMAGINE Phase 3 programs include obesity, cardiovascular-outcomes, maintenance-dose, higher-dose, and type 2 diabetes studies. REDEFINE 4 reported 23% weight loss under the trial-product estimand but did not meet its non-inferiority primary endpoint versus tirzepatide.
Human evidence context
Large Phase 3 programs provide direct human efficacy and safety evidence for the fixed cagrilintide/semaglutide combination. The regulatory application is based on completed pivotal obesity trials while additional Phase 3 studies continue.
Key distinction
CagriSema should be treated as a combination product, not as a single peptide or a generic mixed-vial recipe.
Tracked change history
2 eventsPrimary / developer sources
Verified Sep 6, 2026
Novo Nordisk
Cagrilintide
Mechanism
Long-acting amylin analogue / amylin receptor agonist.
Modality
Peptide analogue
Regulatory context
Investigational; no FDA-approved cagrilintide monotherapy product.
Current program
Novo Nordisk has advanced cagrilintide monotherapy into the RENEW Phase 3 obesity program after Phase 3 REDEFINE data also provided monotherapy evidence.
Human evidence context
Human studies show direct weight-management activity from amylin-pathway treatment, including Phase 3 data generated alongside the CagriSema program.
Key distinction
Cagrilintide monotherapy and CagriSema are separate development programs and should not be treated as interchangeable products.
Primary / developer sources
Verified Sep 6, 2026
Boehringer Ingelheim + Zealand Pharma
Survodutide
Also: BI 456906
Mechanism
Dual glucagon and GLP-1 receptor agonist.
Modality
Peptide dual agonist
Regulatory context
Investigational; no FDA-approved survodutide product.
Current program
The SYNCHRONIZE Phase 3 obesity program includes global obesity, cardiovascular-outcomes, MASLD, and regional studies. SYNCHRONIZE-1 met its primary endpoints and was published in the New England Journal of Medicine in 2026. Survodutide is also in Phase 3 LIVERAGE studies for MASH and fibrosis.
Human evidence context
Survodutide now has published randomized Phase 3 obesity evidence in addition to earlier Phase 2 obesity and MASH studies. In SYNCHRONIZE-1, gastrointestinal symptoms were the most common adverse events and were typically mild to moderate.
Key distinction
Its glucagon/GLP-1 mechanism overlaps conceptually with mazdutide and pemvidutide, but the programs, molecules, evidence, and regulatory status are distinct.
Tracked change history
1 eventOct 8, 2024Phase advancement
MASH Phase 3 program initiated and FDA Breakthrough Therapy designation announced
Source ↗Primary / developer sources
Verified Sep 6, 2026
Innovent Biologics + Eli Lilly
Mazdutide
Also: IBI362
Mechanism
Dual glucagon and GLP-1 receptor agonist.
Modality
Peptide dual agonist
Regulatory context
China's NMPA approved mazdutide for chronic weight management in June 2025. It is not an FDA-approved obesity medication in the United States.
Current program
Innovent continues late-stage development, including the Phase 3 GLORY-2 obesity program evaluating a higher 9 mg strength and Phase 3 diabetes studies in China.
Human evidence context
Mazdutide has randomized Phase 3 evidence and a regional regulatory approval, making it fundamentally different from U.S.-focused investigational programs that have not yet reached any market.
Key distinction
Regulatory status is region-specific: 'approved' here refers to China, not FDA approval in the United States.
Tracked change history
1 eventPrimary / developer sources
Verified Sep 6, 2026
Novo Nordisk
Zenagamtide
Also: Amycretin, NN9487
Mechanism
Unimolecular GLP-1 and amylin receptor agonist.
Modality
Single-molecule peptide dual agonist
Regulatory context
Investigational; no FDA-approved zenagamtide/amycretin product.
Current program
The AMAZE Phase 3 weight-management program began in 2026 and includes subcutaneous and oral development. Novo Nordisk also plans/operates a separate Phase 3 diabetes program.
Human evidence context
Phase 2 studies support direct human metabolic activity, and Novo Nordisk advanced both oral and subcutaneous formulations into Phase 3 weight-management development.
Key distinction
Zenagamtide is the current name for the molecule previously called amycretin; it is one molecule targeting both GLP-1 and amylin receptors, unlike the two-component CagriSema combination.
Tracked change history
1 eventPrimary / developer sources
Verified Sep 6, 2026
Zealand Pharma + Roche
Petrelintide
Mechanism
Long-acting amylin analogue.
Modality
Peptide analogue
Regulatory context
Investigational; no FDA-approved petrelintide product.
Current program
The Phase 2 ZUPREME program studies overweight/obesity with and without type 2 diabetes. Zealand says petrelintide will advance into Phase 3 chronic-weight-management trials with initiation planned for the second half of 2026.
Human evidence context
Human Phase 1 and Phase 2 programs support continued development, but the program should not be described as having completed a Phase 3 efficacy trial yet.
Key distinction
A pipeline label of Phase 3 can describe the program's transition stage even when pivotal trial initiation is still planned; BACToBasics states that distinction explicitly.
Primary / developer sources
Verified Sep 6, 2026
Altimmune
Pemvidutide
Mechanism
Balanced GLP-1 and glucagon receptor dual agonist.
Modality
Peptide dual agonist
Regulatory context
Investigational; no FDA-approved pemvidutide product. FDA has granted Breakthrough Therapy Designation for MASH.
Current program
Pemvidutide completed the MOMENTUM Phase 2 obesity trial. Altimmune's current late-stage strategy has moved into the global PERFORMA Phase 3 MASH program, initiated in August 2026, alongside other liver-disease and alcohol-use programs.
Human evidence context
The molecule has direct human obesity evidence from MOMENTUM, but its active Phase 3 designation currently comes from MASH rather than a new Phase 3 obesity program.
Key distinction
Calling pemvidutide simply a 'Phase 3 obesity drug' would be inaccurate as of September 2026; indication-specific stage matters.
Tracked change history
1 eventPrimary / developer sources
Verified Sep 6, 2026
Amgen
MariTide
Also: Maridebart cafraglutide, AMG 133
Mechanism
GLP-1 receptor agonism combined with GIP receptor antagonism.
Modality
Antibody-peptide conjugate
Regulatory context
Investigational; no FDA-approved MariTide product.
Current program
Amgen's MARITIME Phase 3 program is broad, with chronic-weight-management trials in people with and without type 2 diabetes plus cardiovascular, heart-failure, sleep-apnea, switch, and long-term extension studies.
Human evidence context
MariTide is a late-stage program with a deliberately long-acting design and a mechanism that differs from the incretin agonist combinations commonly grouped with it online.
Key distinction
MariTide is not simply another GLP-1/GIP dual agonist: it activates GLP-1R while antagonizing GIPR and uses an antibody-peptide conjugate design.
Tracked change history
1 eventPrimary / developer sources
Verified Sep 6, 2026
How this page differs from a ranking
Development stage is not a score for effectiveness, safety, or superiority. Cross-trial weight-loss percentages should not be treated as head-to-head comparisons unless the compounds were actually studied against each other in the same trial. This page is designed to answer “what is this program and where does it stand?” rather than “which one should someone use?”
Oldest program verification Sep 6, 2026