generated: '2026-08-04'
method: searched
source: >-
  Diagonal Therapeutics public statements, press releases and trade-press coverage
  (2026-08-04 web search), plus this repo's own probe artifacts
scope: >-
  Diagonal Therapeutics publishes no API, so there are no API or cross-cutting technical
  standards to assert. What it is actually measured against is the clinical and
  regulatory regime for an investigational biologic. That regime is recorded here with
  its status stated honestly - designations granted are recorded as granted, and
  approval, which has not happened, is recorded as not achieved. The API/protocol
  standards block is recorded as not-applicable rather than merely false, so this file is
  never mistaken for a compliance posture the company does not claim.
regulatory_regime:
- id: fda-orphan-drug-designation
  name: US FDA Orphan Drug Designation (21 CFR Part 316)
  conforms: true
  status: granted
  subject: DIAG723 for hereditary hemorrhagic telangiectasia (HHT)
  evidence: >-
    Announced June 2025 - DIAG723 received orphan drug designation from the U.S. FDA for
    the treatment of HHT.
    https://diagonaltx.com/news/diagonals-first-in-class-clustering-antibody-diag723-receives-orphan-drug-designation-odd-from-u-s-fda-and-an-odd-positive-opinion-from-ema-for-treatment-of-hereditary-hemorrhagic-telangiectasia-hht
- id: ema-orphan-designation
  name: EMA Orphan Medicinal Product Designation (Regulation (EC) No 141/2000)
  conforms: true
  status: positive-opinion
  subject: DIAG723 for hereditary hemorrhagic telangiectasia (HHT)
  evidence: >-
    Announced June 2025 alongside the FDA designation - an ODD positive opinion from the
    EMA for DIAG723 in HHT.
- id: fda-ind-clinical-trial
  name: US FDA Investigational New Drug pathway - Phase 1/2 clinical trial conduct
  conforms: true
  status: in-progress
  subject: DIAMOND (NCT07623525)
  evidence: >-
    DIAMOND is a Phase 1/2 multicenter, randomized, double-blind, placebo-controlled
    trial of subcutaneous DIAG723 in adults with HHT; first patient dosed July 2026.
  note: >-
    Recorded as in-progress. The trial is open and enrolling; this is not a marketing
    authorization.
- id: fda-bla-marketing-authorization
  name: US FDA Biologics License Application / marketing approval
  conforms: false
  status: not-reached
  evidence: >-
    No Diagonal Therapeutics product is approved. The lead program is in Phase 1/2.
    Recorded as conforms:false because approval has not been sought or granted at this
    stage of development, not because the company failed a check.
- id: clinicaltrials-gov-registration
  name: FDAAA 801 / ICMJE clinical trial registration
  conforms: true
  status: registered
  evidence: >-
    The DIAMOND trial is registered on ClinicalTrials.gov as NCT07623525. Note that the
    machine-readable record for this trial is published by NIH/NLM through the
    ClinicalTrials.gov API, not by Diagonal Therapeutics.
api_standards:
- id: openapi
  conforms: false
  applicable: false
  evidence: >-
    no public API contract published (see
    well-known/diagonal-therapeutics-well-known.yml)
- id: oauth2
  conforms: false
  applicable: false
- id: openid-connect
  conforms: false
  applicable: false
- id: rfc9457-problem-details
  conforms: false
  applicable: false
- id: asyncapi
  conforms: false
  applicable: false
- id: mcp
  conforms: false
  applicable: false
- id: a2a
  conforms: false
  applicable: false
  evidence: >-
    /.well-known/agent-card.json and /.well-known/agent.json both 404 on diagonaltx.com
    and www.diagonaltx.com
- id: rfc9116-security-txt
  conforms: false
  applicable: true
  evidence: /.well-known/security.txt returns 404 on diagonaltx.com
- id: llms-txt
  conforms: false
  applicable: true
  evidence: >-
    /llms.txt returns 404. The site's robots.txt blocks GPTBot specifically while
    permitting every other AI crawler.
information_security_compliance:
  found: false
  note: >-
    No trust center, SOC 2, ISO 27001, HIPAA attestation or equivalent
    information-security certification page was found by probe-security-programs.py
    (vdp=none trust=none) or by search. No `Compliance`, `TrustCenter` or `Security`
    pointer is wired in apis.yml - and the FDA/EMA designations above are drug-regulatory
    milestones, not a published information-security compliance program, so they do not
    earn one either.
vulnerability_disclosure:
  found: false
  note: >-
    No security.txt, no bug bounty program (HackerOne/Bugcrowd/Intigriti) and no
    responsible-disclosure page were found. probe-security-programs.py returned
    vdp=none.
domain_security_observed:
  source: security/diagonal-therapeutics-domain-security.yml
  summary: >-
    diagonaltx.com serves TLS 1.3 with a certificate valid to 2026-10-04, and publishes
    SPF and DMARC records. HSTS is NOT set, DNSSEC is not enabled, no CAA record is
    published, and the DMARC policy is p=none (monitor only), so neither spoofed mail
    nor a mis-issued certificate would be actively blocked today.