TRANSPARENCY DESK

Sources & methodology

Separate the source’s statement from our interpretation. Date both. Keep a correction trail.

This is a research snapshot, not a live FDA feed. Dates do not automatically refresh when someone visits the page. Sponsor announcements remain sponsor claims, including those hosted by SEC. Two source entries disclose retrieval limitations.

Review-timing calculation

Submission range: January 1–March 31, 2027. For each endpoint add 60 calendar days, then 10 calendar months for standard or 6 for hypothetical priority review. Publish rounded month ranges rather than false day-level precision. No probability is attached. A verified agency/sponsor-announced target action date supersedes the scenario, not the approval uncertainty.

Search Pulse calculation

Website-export mode only: use one Google Trends CSV covering a full, consistently selected window for the term “retatrutide,” U.S., Web Search, All categories. Keep 52 completed weekly observations from the same extraction. The displayed index is the latest complete week. Compare the most recent four-week mean with the preceding four-week mean in the same extraction. Suppress the comparison for missing/censored data or a baseline mean below 5. This floor is an editorial stability rule, not a Google standard.

Archive the original export, extraction date, settings, data coverage and SHA-256. Never splice normalized exports, call the index absolute search volume, infer purchase intent or feed it into the regulatory model. No source data is loaded in this prototype.

Source ledger

S01
Regulatory guidance · FDA

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss ↗

Retatrutide is not a component of an FDA-approved drug; FDA states it cannot be used in compounding under federal law.

Publication: See agency page; page is updated · Checked: 2026-09-14

S02
Sponsor statement in SEC archive · Eli Lilly and Company

Second-quarter 2026 results, Exhibit 99.1 ↗

Lilly describes its planned retatrutide application as a BLA and plans submission in Q1 2027. This is a company plan, not FDA acceptance or approval.

Publication: 2026-08-05 · Checked: 2026-09-14

S03
Sponsor announcement · Eli Lilly and Company

Retatrutide successful in two additional Phase 3 obesity trials ↗

Sponsor announcement of TRIUMPH-2 and TRIUMPH-3 topline results and intended Q1 2027 filing. Not an FDA determination.

Publication: 2026-07-23 · Checked: 2026-09-14

S04
Review-performance framework · FDA

PDUFA VII performance goals, section I.A.1, printed page 4 ↗

For original BLAs and NME NDAs, standard and priority goals are 10 and 6 months respectively after the 60-day filing date. These are action goals, not promised approvals.

Publication: FY 2023–2027 framework · Checked: 2026-09-14

S05
Review-process explanation · FDA

Priority Review ↗

Priority review is an FDA designation; it is not assumed from publicity or commercial interest.

Publication: See agency page · Checked: 2026-09-14

S06
Government educational resource · NIH

Finding a Clinical Trial ↗

Trial listings are not federal endorsement; participation requires discussion of risks and potential benefits.

Publication: 2025-04-24 · Checked: 2026-09-14

S07
Official registry search · ClinicalTrials.gov / NLM

Search retatrutide trial records ↗

Route to original registry records. No recruiting status or eligibility is reproduced in this prototype.

Publication: Records change individually · Checked: 2026-09-14

S08
Sponsor access information · Lilly Medical

Is there an expanded access program for retatrutide? ↗

Official search excerpt states Lilly supports individual requests subject to criteria and geography. Full eligibility text was not accessible in the research tool; recheck at publication.

Publication: Not established from retrieved page · Checked: 2026-09-14

S09
Government educational resource · FDA

Expanded Access ↗

Expanded access is a distinct investigational pathway, not general commercial approval.

Publication: See agency page · Checked: 2026-09-14

S10
Advertising guidance · FTC

Health Products Compliance Guidance ↗

Express and implied health claims require appropriate substantiation; disclaimers cannot cure a contradictory overall impression.

Publication: 2022 guidance · Checked: 2026-09-14

S11
Advertising guidance · FTC

Native Advertising: A Guide for Businesses ↗

Advertising must be recognizable; necessary disclosures must be clear and prominent. Search-index text retrieved; full page fetch unavailable.

Publication: 2015-12-21 · Checked: 2026-09-14

S12
Commercial email guidance · FTC

CAN-SPAM Act: A Compliance Guide for Business ↗

Accurate identity and subject lines, required commercial-email disclosures, postal address and functioning opt-out.

Publication: See agency page · Checked: 2026-09-14

S13
Statute · Washington State Legislature

RCW 19.373.030 — Collection or sharing of consumer health data ↗

Collection and sharing rules, exceptions and consent disclosure requirements. Applicability requires review of actual data flows.

Publication: Current code retrieved · Checked: 2026-09-14

S14
Statute · Washington State Legislature

Chapter 19.373 RCW — My Health My Data ↗

Definitions, notices, rights, security, processors, and distinct authorization requirements for sales, with statutory exceptions.

Publication: Current code retrieved · Checked: 2026-09-14

S15
Measurement methodology · Google

FAQ about Google Trends data ↗

Website data are sampled/normalized relative search-interest indices, not absolute search counts or purchase intent.

Publication: See Google Help · Checked: 2026-09-14

S16
Data export documentation · Google

Export, embed, and cite Trends data ↗

CSV export and attribution support a low-cost manual update workflow.

Publication: See Google Help · Checked: 2026-09-14

S17
API documentation · Google

Google Trends API Alpha ↗

Access remains application-based alpha; the API scaling differs from website 0–100 exports. Do not assume credentials or equivalent scales.

Publication: Current documentation · Checked: 2026-09-14

S18
Database disclaimer · NLM / NIH

PubMed Disclaimer ↗

Indexing or archiving is not NIH endorsement of a study or a product.

Publication: See NLM page · Checked: 2026-09-14

S19
Federal regulation · eCFR

21 CFR 312.7 — Promotion of investigational drugs ↗

Restrictions address sponsors, investigators and persons acting on their behalf; scientific exchange is distinguished from promotion. Manufacturer control/sponsorship requires renewed review.

Publication: Code current to 2026-09-10 in retrieved page · Checked: 2026-09-14

S20
Destination spot-check · GLP-1Finder

Public landing page ↗

Retrieved 2026-09-16. Self-declared 'verified providers' and 'Trusted by thousands monthly' claims without visible methodology or audit reference. Substantiated efficacy comparisons (semaglutide 15–20% body-weight loss; tirzepatide 22–26%) presented without specific citations. Hold promotion pending visible verification backbone and source-linked efficacy figures.

Publication: Live retrieval · Checked: 2026-09-16

S21
Destination spot-check · Peptides-Finder

Public landing page ↗

Retrieved 2026-09-16. Root page lists retatrutide alongside FDA-approved peptides (BPC-157, Tirzepatide, Semaglutide) as a 'verified offering.' This contradicts RetaFinder's position that retatrutide is investigational and cannot be compounded under federal law (see S01). Embedded clinic data appears to be auto-generated from the TRT-Finder Airtable sync without peptide-specific verification. Hold promotion pending retatrutide removal or clear investigational-only framing.

Publication: Live retrieval · Checked: 2026-09-16

S22
Destination spot-check · HRT-Finder

Women’s Hormone Finder landing page ↗

Retrieved 2026-09-16. Page asserts HRT is 'the most effective treatment for menopausal symptoms' and recommends A4M certification as a provider-selection signal, both without specific source citations. Approved-versus-off-label-versus-compounded distinctions are not drawn. Hold promotion pending source attribution for efficacy claim, A4M reference reframed or removed, and clearer approved/off-label/compounded framing.

Publication: Live retrieval · Checked: 2026-09-16

S23
Destination spot-check · TRT-Finder

Public landing page ↗

Retrieved 2026-09-16. Verification backbone disclosed: MedVerity by Signal Loom AI, cross-checked against NPI Registry, state medical boards and federal sources. Specific counts disclosed (375+ providers, 30+ telemedicine, 190+ in-person). Common-ownership disclosure: AIM Elemental Group / HormoneVentures, LLC. Sister-publisher disclosure: AEGCompliance. Clear disclaimer: 'not a medical referral service.' No implied cure or comparative efficacy claims on the root page. Approved 2026-09-16 for sponsored outbound with adjacent relationship disclosure.

Publication: Live retrieval · Checked: 2026-09-16

S24
Search policy · Google Search Central

Spam policies for Google web search ↗

Avoid doorway sites, scaled low-value pages and link schemes; useful original editorial content is the proposed strategy.

Publication: Current documentation · Checked: 2026-09-14

S25
Regulatory framework · FDA

Drug Applications — overview of NDA, BLA, IND and other pathways ↗

Defines application types and where each pathway applies. Biologic peptide therapeutics use the BLA pathway.

Publication: See agency page · Checked: 2026-09-15

S26
Device framework · FDA

Premarket Notification 510(k) ↗

510(k) is the medical-device clearance pathway; it is not the drug application pathway. Included for completeness because the term appears in combination-product and device coverage.

Publication: See agency page · Checked: 2026-09-15

S27
Review designation · FDA

Breakthrough Therapy ↗

Breakthrough designation criteria, process and effect on review. Distinct from priority review and accelerated approval.

Publication: See agency page · Checked: 2026-09-15

S28
Review designation · FDA

Fast Track ↗

Fast track criteria, sponsor-agency interaction frequency and review effect. Distinct from breakthrough, priority review and accelerated approval.

Publication: See agency page · Checked: 2026-09-15

S29
Approval pathway · FDA

Accelerated Approval Program ↗

Approval based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit; post-marketing confirmatory trials typically required.

Publication: See agency page · Checked: 2026-09-15

S30
Post-approval framework · FDA

Risk Evaluation and Mitigation Strategies (REMS) ↗

REMS may impose prescribing, dispensing, or monitoring requirements; not all approved drugs carry a REMS.

Publication: See agency page · Checked: 2026-09-15