Clinical Development Tracker

From Preclinical Research to FDA Approval

Follow the highest credible development milestone for every compound in BACToBasics, then see the dated changes that moved selected programs from one stage to another. The tracker separates active programs, historical programs, approved products, and compounds that do not have an established modern clinical-development pathway. New to these labels? Start with preclinical research, Phase 1, Phase 2, and Phase 3.

Change history

What actually changed over time

Dated milestones are stored separately from each compound's current snapshot. A verification date is not treated as a development event, and BACToBasics only adds timeline entries when a dated source supports a meaningful change or readout.

14

Events

11

Programs

4

Approvals

14 matching events · 3 tracked phase advances overall

Aug 3, 2026Phase advancementPemvidutideLatest tracked change

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.

Phase 2Phase 3 — MASH
May 21, 2026Trial readoutRetatrutide

TRIUMPH-1 delivered positive pivotal Phase 3 results

Lilly reported positive topline results from TRIUMPH-1, providing the first pivotal Phase 3 obesity readout for retatrutide while the drug remained investigational.

Phase 3
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.

Phase 2Phase 3
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.

U.S. FDA review
Dec 18, 2025Regulatory submissionCagriSemaUnited States

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.

Phase 3U.S. FDA review
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.

Phase 3
Aug 15, 2025ApprovalSemaglutideUnited States

Wegovy received accelerated FDA approval for MASH

FDA granted accelerated approval for Wegovy injection for noncirrhotic MASH with moderate-to-advanced fibrosis in adults, adding another product-specific semaglutide indication.

Approved
Jun 27, 2025ApprovalMazdutideChina

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.

Phase 3Approved in China

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What a development stage does — and does not — mean

A Phase 2 or Phase 3 label describes a research milestone, not a recommendation to use a compound and not proof that approval will follow. Historical programs may have been completed, terminated, or simply never advanced further.

FDA approval is product- and indication-specific. An approved molecule is not automatically approved for every use discussed online.

Exact compound identity matters

BACToBasics only assigns a development milestone when the evidence matches the exact compound and relevant route closely enough to be meaningful. CJC-1295 with DAC is not interchangeable with “CJC-1295 No DAC,” TB-500 is not full-length thymosin beta-4, and topical GHK-Cu studies do not establish injectable clinical development.

We also do not count ClinicalTrials.gov records that explicitly call themselves fictional or example studies as real development milestones.

How change history is maintained

Current status and historical events are separate records. Updating a verification date does not automatically create a timeline item. A change-history entry needs a dated source and a material event such as a phase transition, pivotal readout, regulatory submission, approval, trial completion, or program-status change. If a compound has no stored timeline events, BACToBasics shows its current verified snapshot without inventing a backfilled history.

BACToBasics provides educational research context only. Development-stage and change-history information is not medical advice, dosing advice, treatment guidance, or a recommendation to use any peptide or medication. Trial and regulatory status can change; primary sources should be checked for the latest status.