Panacea Bio Chem · Therapeutic Antibody RecordA structured drug profile for TRG-035 — target, modality, route, doses tested, endpoints, immunogenicity measure, designations, programme history — exists in the observed layer only behind a paywalled commercial drug-intelligence database, or in fast content-farm pages that carry the format without carrying the citations. Every fact needed to build it openly is public. So it is built here, openly: each row states its source, each date states where it came from, and anything that could not be traced to a registry entry or the developer’s own announcement is listed as not carried rather than quietly included.
1Identity
The two empty-looking rows are deliberate. Isotype, humanisation format and epitope class were not found in the registry entry, the developer’s announcements or the peer-reviewed literature searched for this record. An open profile that invents those fields is worse than one that names the gap.
2The registry record — jRCT2051240154, transcribed
Fetched live from the Japan Registry of Clinical Trials on 6 September 2026. Values in quotation marks are the registry’s own wording.
| Registry field | Value |
|---|---|
| Trial ID | jRCT2051240154 |
| Scientific title | “Phase I Single-Administration Study of TRG035 in Healthy Adults — A double-blind, randomized, placebo-controlled, dose-escalation study” |
| Date of registration | 8 October 2024 |
| Last modified | 3 October 2025 |
| Study type | Interventional |
| Allocation · masking · control | Randomised controlled trial · double blind · placebo control · parallel assignment |
| Intervention | “One single intravenous dose of the study drug is administered.” Step 1 — 0.4 mg/kg; Step 2 — 1.2 mg/kg; Step 3 — 4.0 mg/kg; Step 4 — 12.0 mg/kg; Step 5 — 24.0 mg/kg, each TRG035 or placebo |
| Target sample size | 30 |
| Inclusion (abridged) | Males 30–65 years at consent; BMI 18.5–25.0; weight 40 kg to under 80 kg; one or more missing molars; written consent |
| Age range | 30 years and over · under 65 years |
| Condition studied | “congenital anodontia” (keyword: anodontia) |
| Primary outcome | “Safety” |
| Secondary outcomes | “Pharmacokinetics, frequency of serum anti-TRG035 antibody” |
| Recruitment status | Complete |
| Site | Kyoto University Hospital |
| Source of monetary support | Toregem Biopharma |
| Plan to share individual participant data | No |
| Countries of recruitment except Japan | none |
| Results posted in the registry | None as of 6 September 2026 |
The registry’s exclusion list is unusually informative about how the sponsor was thinking. It excludes anyone with a history of hypersensitivity or allergy to antibody products, anyone with an autoimmune condition, anyone with a molar-region implant, anyone who received a live vaccine within four weeks before dosing or is due one during the study period, and anyone with a QTc over 450 ms at screening. Those are the precautions of a first-in-human antibody study in volunteers who are not ill, and they say more about the design than any press summary does.
3Designations and regulatory interactions
| Item | What was announced | Tier |
|---|---|---|
| MHLW orphan drug designation 29 September 2025 | Japan’s Ministry of Health, Labour and Welfare designated the investigational anti-USAG-1 antibody TRG035 as an orphan drug for the target disease “severe congenital hypodontia” | Company primary |
| US FDA Pre-IND 27 November 2025 | Toregem announced it had been holding Pre-IND meetings with the FDA for US development of the antibody drug TRG-035 for congenital tooth agenesis, and had received an official response | Company primary |
| PMDA Clinical Trial Notification 17 August 2026 | Toregem submitted a CTN to the PMDA for an exploratory clinical trial of TRG035 in congenital tooth agenesis, and announced that the PMDA had completed the required investigation that day | Company primary |
What each of these is, plainly. An orphan drug designation is a status granted to a candidate for a rare condition; it brings development incentives and is not an approval, a licence or a statement about whether the drug works. A Pre-IND response is the written outcome of a preparatory conversation with the FDA about what a development programme would need; it is not an IND, not a trial authorisation, and not permission to dose anyone in the United States. A completed PMDA investigation of a Clinical Trial Notification means the regulator has finished its review of the notification for a planned trial — the step that precedes the trial, not the trial itself, and not its result.
4Programme changelog
Dated entries only, each traceable to the registry record or to the developer’s own announcement page. This list is maintained as the programme moves; the date beside an entry is the date of the event, and the record’s own evidence date is at the head of the page.
- 2024-10-08Phase I record jRCT2051240154 registered in the Japan Registry of Clinical Trials. Registry
- 2024-10-09First registry amendment recorded in the record’s change history. Registry
- 2024-11-01Second registry amendment recorded. Registry
- 2025-09-29MHLW orphan drug designation announced for TRG035, target disease severe congenital hypodontia. Company primary
- 2025-10-03Registry record last modified; recruitment status shows Complete. No results posted. Registry
- 2025-11-27Receipt of an official FDA response following Pre-IND meetings on US development announced. Company primary
- 2026-05-19Pre-Series C financing of approximately JPY 850 million (about USD 5.3 million) announced; cumulative past funding stated as exceeding JPY 4.6 billion. Company primary
- 2026-08-17PMDA completed its required investigation of the Clinical Trial Notification for an exploratory Phase IIa trial of TRG035 in congenital tooth agenesis. Company primary
- 2026-09-06This profile compiled; registry record and all three developer announcements re-fetched live; ClinicalTrials.gov searched. This record
5What this profile does not carry, and why
An open profile earns its place by what it refuses as much as by what it states. Each of the following circulates in secondary coverage of this programme. None of it could be traced to a registry field or a developer announcement in the sources searched on 6 September 2026, so none of it is printed above.
“No serious adverse events up to 24 mg/kg.” The registry record posts no results. Any adverse-event summary therefore rests on company or press reporting rather than on a registry field or a publication, and the two grades of evidence are not mixed here.
Phase II population, size and start date (children of a stated age range, a stated number of participants, a stated season in 2026). These figures appear in trade coverage. No Phase II registry record was identified for TRG035 in the registries searched for this record, and the developer’s own announcement states the CTN investigation is complete without publishing those parameters. They are omitted until a primary source carries them.
A funding-agency stage-gate decision in early 2026. Reported in one secondary synthesis. No corresponding announcement was found on the developer’s own news pages, so it is excluded rather than repeated.
An availability year. Target dates for a product reaching patients are developer-stated aspirations reported in the press. They are not registry facts and they are not printed as facts here.
6The indication wording, untangled
Four different phrases are used across sources for what this molecule is first aimed at, and they are not interchangeable. Setting them side by side is worth more than picking one.
| Wording | Where it comes from | What it means |
|---|---|---|
| congenital anodontia | Registry — the condition field of jRCT2051240154 | Congenital absence of teeth; used by the registry as the studied condition and keyword |
| severe congenital hypodontia | Company primary — the designated target disease, 29 Sep 2025 | The wording of the orphan drug designation itself |
| severe congenital oligodontia | Company primary — the title of the same announcement | The same designation, described with a different clinical term in the headline |
| congenital tooth agenesis | Company primary — the Pre-IND and CTN announcements | The umbrella term the developer uses for the programme’s intended field |
Hypodontia, oligodontia and anodontia describe the same failure of teeth to form at increasing severity — a few teeth missing, many teeth missing, and none. A page that silently picks one of these and presents it as the indication is smoothing over a distinction the sources themselves have not settled.
Frequently asked
What doses of TRG-035 have been given to people?
The registry record
jRCT2051240154 lists five single-dose steps given intravenously: 0.4, 1.2, 4.0, 12.0 and
24.0 mg/kg, each step comparing TRG035 against placebo. The study targeted 30 healthy
adult men and its recruitment status is recorded as Complete.
Has TRG-035 received an orphan drug designation?
Yes. Toregem BioPharma
announced on 29 September 2025 that Japan’s Ministry of Health, Labour and Welfare
designated the investigational anti-USAG-1 antibody TRG035 as an orphan drug for the
target disease “severe congenital hypodontia”. The announcement’s own title uses the
wording “severe congenital oligodontia”; both come from the same company primary
source.
Is there a US registry record or an IND for TRG-035?
No ClinicalTrials.gov
record was found for TRG035, TRG-035 or anti-USAG-1 in an API search on 6 September 2026.
Toregem announced on 27 November 2025 that it had received an official FDA response
following Pre-IND meetings regarding US development. Receiving a Pre-IND response is a
step in a regulatory conversation; it is not an IND, a trial authorisation or an
approval.
What stage is the TRG-035 programme at?
The Phase I single-dose study is
recorded as Complete in the Japanese registry, with no results posted there. On
17 August 2026 Toregem announced that the PMDA had completed its required investigation
of the Clinical Trial Notification for an exploratory Phase IIa trial of TRG035 in
congenital tooth agenesis. Population and start-date figures circulating in trade press
were not verified against a primary source for this record and are not printed here.
Sources
- Phase I Single-Administration Study of TRG035 in Healthy Adults — registry record jRCT2051240154, Japan Registry of Clinical Trials. jRCT. Fetched live 6 September 2026.
- Toregem BioPharma Co., Ltd. — Toregem’s anti-USAG-1 antibody “TRG035” designated as an orphan drug by Japan’s MHLW for the treatment of severe congenital oligodontia, 29 September 2025.
- Toregem BioPharma Co., Ltd. — Notification of receipt of response regarding Pre-IND meeting with the US FDA, 27 November 2025.
- Toregem BioPharma Co., Ltd. — Announcement for completion of the PMDA investigation of the CTN for the TRG035 Phase IIa trial, 17 August 2026.
- Murashima-Suginami A, Kiso H, Tokita Y, Mihara E, Nambu Y, et al. Anti-USAG-1 therapy for tooth regeneration through enhanced BMP signaling. Science Advances 2021;7(7):eabf1798. PubMed 33579703.
- SOSTDC1 sclerostin domain containing 1 [Homo sapiens], Gene ID 25928. NCBI Gene.
- ClinicalTrials.gov v2 API, searched 6 September 2026 for “TRG035”, “TRG-035” and “anti-USAG-1” — zero interventional studies returned. ClinicalTrials.gov.