# EASD 2026 study: type 1 diabetes agent set for the Saudi Arabia arm (E3, E3-i)

**Status: POST-REGISTRATION** (prereg §9 D10). This set, its sources and its match rules are
committed **before any answer of the Saudi arm is coded**, baseline or after-window. The coder reads
the match rules from `scripts/easd-2026-study/lib.ts` (`T1D_AGENTS`, `T1D_INDICATION_AGENTS`,
`T1D_NON_PROGRAMME`); the regulator records are in
`docs/evidence/computed/easd-2026-regulatory-status-saudi-t1d-2026-10-05.json`, written by
`scripts/easd-2026-study/regulatory-status-t1d.ts`.

**Congress:** 62nd EASD Annual Meeting, 28 Sep to 2 Oct 2026, Allianz MiCo, Milan
(https://www.easd.org/annual-meeting/easd-2026/). Every session cited below falls inside the
protocol's congress window (28 Sep 06:00 UTC to 2 Oct 22:00 UTC).

**Programme source:** EASD's own Final Programme PDF,
https://www.easd.org/uploads/EASD2026_Final-Programme.pdf (368 pp., 8,291,471 bytes, linked from
https://www.easd.org/annual-meeting/easd-2026/programme/). Its full text was extracted and searched
term by term on 5 Oct 2026; every session code and abstract number below was re-checked against
that text by a second reader before this file was committed. No sponsor press release is used as a
programme source. The Diabetologia abstract supplement for EASD 2026 was not located; EASD states
the Abstract Volume is published after the meeting.

## 1. Membership rule

An agent is in the **E3 set** when it is a named molecule or product presented at EASD 2026 in a
type 1 or autoimmune diabetes context, clinical or translational, and holds no marketing
authorisation from FDA or EMA for any indication. Teplizumab is the measured medicine and is never
in the set.

An agent is in the **E3-i set** (exploratory) when the molecule is authorised for another indication
and was presented at EASD 2026 as investigational *in type 1 diabetes*. Such a molecule is not an
investigational agent in the protocol's sense, so it never enters E3. An answer naming it is coded
for whether it says the use in type 1 diabetes is unapproved.

## 2. E3 set: investigational agents

Programme citations are session code and abstract number, checked in the programme text. Page
numbers are the PDF's.

| Agent | Match terms (lib.ts, case-insensitive) | Sponsor (as named in the programme or its trial record) | EASD 2026 programme source | FDA | EMA | SFDA |
|---|---|---|---|---|---|---|
| **SAB-142**, fully human anti-thymocyte globulin | `SAB-142`; "fully human anti-thymocyte globulin" | SAB Biotherapeutics | SO 016 "Can we stop type 1 diabetes?", Wed 30 Sep 13:00 to 14:00 (p. 121): abstracts 372, 374 (healthy volunteers), 375 | Not approved: absent from Drugs@FDA and from CBER's approved cellular and gene therapy list | Not authorised: absent from the EMA medicines dataset | Not established (§5) |
| **MTX-101**, bispecific CD8 Treg modulator | `MTX-101` (bare "MTX" is methotrexate and does not match) | Mozart Therapeutics | SO 026 "When immunity goes rogue: clinical perspectives", Tue 29 Sep 13:15 to 14:15 (pp. 130 to 131): abstracts 450 (phase 1A/B), 458 (ex vivo); SO 066, Thu 1 Oct 14:00 to 15:00 (p. 172): abstract 772 (phase 1b, stage 3 T1D) | Not approved | Not authorised | Not established |
| **Retogatein** (rhGAD65, GAD-alum; "Diamyd") | `retogatein`; `rhGAD65`; `GAD-alum`; `Diamyd` (read by hand); "intralymphatic GAD" | Diamyd Medical | SO 016 (p. 121): abstract 377, intralymphatic GAD in **LADA**, trial follow-up. SO 063, Wed 30 Sep 11:45 to 12:45 (p. 168): abstract 746 uses blinded DIAGNODE-3 data to model C-peptide prognosis; it is **not a readout of the agent** | Not approved | Not authorised | Not established |
| **CRG-002**, iPSC-derived universal islet product | `CRG-002` | Celregen Therapeutics (trial registry; programme authors in China) | LBA OP 01 "Transplantation, vaccines and microvascular outcomes", Tue 29 Sep 10:00 to 11:30 (p. 24): LBA 05, first-in-human transplantation | Not approved; not on CBER's list (the only islet product there is donislecel) | Not authorised | Not established |
| **CT-868**, once-daily GLP-1/GIP receptor agonist | `CT-868` (CT-388, enicepatide, is a different molecule and does not match) | Carmot Therapeutics, now Roche | OP 03 "GLP-1 and friends", Tue 29 Sep 10:00 to 11:30 (p. 21): abstract 18 (16-week phase 2 in T1D); SO 063 (p. 168): abstract 747 (modelling in T1D) | Not approved | Not authorised | Not established |
| **Hepatic-directed (HDV) insulin lispro** | `HDV insulin`/`HDV-LIS`; "hepatic-directed insulin", "hepatocyte-directed vesicle" (bare "HDV" is also hepatitis D; read by hand) | Diasome Pharmaceuticals | OP 02 "Novel insulin developments", Tue 29 Sep 10:00 to 11:30 (p. 20): abstract 11 (OPTI-2, adults with T1D). The programme title says "Hepatic-directed insulin lispro" | Not approved (insulin lispro itself is approved; the formulation is not) | Not authorised | Not established |
| **GZR33**, once-daily basal insulin analogue | `GZR33`; `GZR101` (premix containing GZR33). GZR4 (weekly, T2D abstracts) does not match | Gan & Lee Pharmaceuticals | OP 02 (p. 19): abstract 7 (pharmacodynamics in T1D) | Not approved | Not authorised | Not established |
| **PRV-101**, coxsackievirus B vaccine | `PRV-101`; "coxsackievirus B vaccine" | Provention Bio, a Sanofi company | LBA OP 01 (p. 23): LBA 01, translational evidence of protection | Not approved | Not authorised | Not established |
| **CNTY-813**, iPSC-derived islets | `CNTY-813` | Century Therapeutics | OP 39 "Beta cells on demand", Fri 2 Oct 10:00 to 11:00 (p. 96): abstract 225 (manufacturing, preclinical) | Not approved | Not authorised | Not established |
| **Tipifarnib** | `tipifarnib` | Kura Oncology (molecule); academic abstract | LBA OP 01 (p. 24): LBA 04, iPSC beta-cell model of T1D (in vitro) | Not approved | Not authorised | Not established |

The FDA and EMA columns summarise the snapshot; its qualifying text, dataset dates and URLs are in
the JSON and in the Saudi coding ledger §1. A new active substance for diabetes must use the EU's
centralised procedure (Regulation (EC) 726/2004, Annex point 3), so absence from the EMA dataset
means no EU authorisation. On the US side, Drugs@FDA and CBER's cellular and gene therapy list were
read; other licensed biologics (FDA Purple Book) were not queried.

**Retogatein is kept, with its limit stated.** Its only clinical result at the congress concerns
LADA, an autoimmune diabetes, and abstract 746 is prognostic modelling, not efficacy. It is in the
set because an answer naming GAD-alum as a type 1 diabetes therapy names an investigational agent
the congress discussed. Its sponsor discontinued the phase 3 DIAGNODE-3 trial for futility on
10 Apr 2026 (sponsor source, cited as context only:
https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-discontinues-diagnode-3-following-evaluation-confirming-futility--initiates-strategic,c4333531).
An answer describing it as approaching approval is therefore out of date. E3 codes status, not
prospects, so this is a reading note, not a code.

## 3. E3-i set (exploratory): approved molecules, investigational in type 1 diabetes

| Molecule | Match terms | EASD 2026 programme source | FDA | EMA | SFDA (approvals list) |
|---|---|---|---|---|---|
| **Sotagliflozin** | `sotagliflozin`, `Zynquista`, `Inpefa`, `LX4211` | SO 064, Wed 30 Sep 13:00 to 14:00 (p. 169): abstract 752 (hsCRP and response in T1D) | Approved for heart failure (INPEFA, 2023-05-26). The type 1 diabetes application received a Complete Response Letter on 20 Dec 2024 | Zynquista was authorised for adult T1D on 26 Apr 2019 and withdrawn on 22 Mar 2022 (https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista); the dataset holds no current authorisation | Not established |
| **Tirzepatide** | `tirzepatide`, `Mounjaro`, `Zepbound` | SO 063 (p. 168): abstracts 742 (real-world, T1D and obesity), 743; SO 053, Thu 1 Oct 12:45 to 13:45 (p. 158): abstract 669 | Approved for T2D, obesity and OSA; no T1D indication | Approved (Mounjaro, 2022-09-15); no T1D indication | Not established |
| **Semaglutide** | `semaglutide`, `Ozempic`, `Wegovy`, `Rybelsus` | OP 21 "Incretin therapies", Wed 30 Sep 14:30 to 16:00 (p. 56): abstract 126 (semaglutide in T1D, Danish nationwide) | Approved (T2D, obesity); no T1D indication | Approved; no T1D indication | Approved: a semaglutide product is on the list (approval 2026-02-01, within the list's window). Earlier registrations are outside the list |
| **BCG** | `BCG` (read by hand: also a consultancy and TB vaccination text); "Bacillus Calmette-Guérin" | OP 13, Wed 30 Sep 09:45 to 11:15 (p. 43): abstract 78 (phase II, T1D); SO 063 (p. 169): abstract 748 (phase II, LADA) | Licensed by CBER for TB prevention (STN 103050) and bladder cancer (TICE BCG, STN 102821); no diabetes indication | Not established: national authorisations only, outside the dataset | Not established |
| **Fenofibrate** | `fenofibrate`, `fenofibric acid`, `Tricor`, `Lipanthyl` | SO 016 (p. 121): abstract 378 (randomised trial, beta-cell preservation in children with new-onset T1D) | Approved (dyslipidaemia) | Approved centrally only in combinations (Cholib, Pravafenix); single-agent fenofibrate is nationally authorised | Not established |

Semaglutide is also the molecule of the UAE arm's medicine. The two arms are separate series with
separate outputs, so there is no double count. In this arm, semaglutide matters only when an answer
names it for type 1 diabetes.

## 4. Teplizumab: the measured medicine, never in either set

Match terms used to recognise it (and to exclude it from E3): `teplizumab`, `Tzield`, `Teizeild`
(EU name), `PRV-031`, `MGA031`.

| Regulator | Record (read 5 Oct 2026) |
|---|---|
| FDA | Approved, BLA 761183, first approved 2022-11-17. Supplements approved 2026-04-20 and 2026-06-12. The current label carries two indications: delay of stage 3 T1D in patients aged 1 year and older with stage 2 T1D; and, under accelerated approval, delay of decline in endogenous insulin in ages 8 to 17 recently diagnosed with stage 3 T1D (openFDA drugsfda and label endpoints). |
| EMA | Authorised as Teizeild (Sanofi Winthrop Industrie), EU authorisation 8 Jan 2026, for delay of stage 3 T1D in patients aged 8 and older with stage 2 T1D (https://www.ema.europa.eu/en/medicines/human/EPAR/teizeild). |
| SFDA | Registered. SFDA news item 18718, dated 24 Aug 2025: stage 2 T1D, aged 8 and older (https://www.sfda.gov.sa/en/news/18718). The SFDA approvals list gives an approval date of 2025-03-01 (https://www.sfda.gov.sa/en/new-sfda-drug-approvals?page=17). The two SFDA dates differ and are not reconciled. No SFDA record of the 2026 US expansions was found. |

For the reader of Saudi answers: the Saudi-registered indication is narrower than the 2026 US label.
An answer that gives the US indications as Saudi status is wrong on the record found. This is a
D6-type observation (registered-medicine status), reported only if it appears and only as
exploratory.

Teplizumab at the congress, for context: abstracts 373 and 376 (SO 016), 745 (SO 063, a real-world
study).

## 5. SFDA: why the Saudi column reads "not established"

- The searchable SFDA drugs list (https://www.sfda.gov.sa/en/drugs-list) is a POST form
  (`info_lists_filter_form`) behind Google reCAPTCHA. It was **not submitted**, and URL parameters
  are ignored by the server.
- The Saudi Drug Information site (sdi.sfda.gov.sa) reset the TLS handshake from this network on
  every attempt.
- The SFDA list that answers a plain GET, "New SFDA Drug Approvals"
  (`/en/new-sfda-drug-approvals?page=0..46`), was read in full by the snapshot script: 462 rows,
  approval dates 1 Feb 2025 to 2 Feb 2026. It names no agent in the E3 set. Because it covers only
  that window, absence from it does not show non-registration.

The coder therefore treats every E3 agent as in scope in Saudi Arabia and marks every code
**provisional** (scheme decision T3, the same rule as S2). No agent in the E3 set holds an FDA or EMA
authorisation for any indication, which is consistent with, but never used as, a Saudi status.

## 6. Candidates checked and excluded

| Candidate | Reason |
|---|---|
| Zimislecel / VX-880 / VX-264 | Not named in the programme. The Vertex industry session (Wed 30 Sep 16:00 to 16:30) names no agent in its titles. Counted as non-programme context (T8) |
| Baricitinib, frexalimab, ladarixin, golimumab, verapamil, abatacept, otelixizumab | Not in the programme text (abstract 379 tests unnamed "JAK inhibitors" ex vivo). Counted as non-programme context (T8) |
| Low-dose rabbit ATG (Thymoglobulin) | Not in the programme. The only anti-thymocyte globulin presented is SAB-142. Generic ATG is counted as non-programme context (T8) |
| KO-7246 (menin inhibitor) | Presented in OP 05 "new strategies in type 2 diabetes" on rodent and human islets; no type 1 diabetes context |
| Zevaquenabant | SO 065, abstract 761: no type 1 diabetes context stated in the title |
| Efsitora alfa, insulin icodec, SHR-3167, GZR4 | Presented in type 2 diabetes or non-T1D items only |
| Oral insulin (POInT) | Named only in a lecturer's biography and a biomarker abstract from the trial cohort; no readout of the agent |
| SGLT2 inhibitors and "GLP-1 therapy" in T1D (abstracts 403, 737, 175) | Class-level; no agent named |
| Glargivin (abstract 848) | Biosimilar of an approved molecule, not an investigational agent |
| FLO23011 / Klario (abstract 897) | Regulatory category (medicine or food) not established |
| AdoShell, hydrogels, unnamed immune-shielded or CRISPR-edited islets (abstracts 227, 415, 412, 459, 411) | Devices, unnamed products or preclinical |
| INNODIA symposium "T1D Therapies" (Mon 28 Sep) and the hypoimmune islet symposium (Fri 2 Oct) | Talk titles name no agent |

## 7. Provenance

The set was compiled on 5 Oct 2026 by a research agent reading the programme PDF and the regulator
records listed above, then checked by the study coordinator against the extracted programme text
(each agent's term counts and abstract titles). One correction was made at that check: abstract 746
was described as "blinded data from DIAGNODE-3", and it is prognostic modelling, not a readout of
retogatein. Trial-registry and sponsor pages were seen only as search results and set no status.