Toregem BioPharma
Toregem BioPharma is a Kyoto University spin-off developing TRG035, a humanized anti-USAG-1 antibody designed to regenerate natural teeth in patients with congenital edentulism. The clinical-stage biotech is preparing Phase II trials in Japan and US clinical entry, targeting rare genetic tooth agenesis first.
- Company typePrivate
- Founded2020
- HeadquartersKawaramachi, Japan
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Toregem BioPharma does
Toregem BioPharma Co., Ltd. is a privately held, Kyoto University spin-off biopharmaceutical company founded in May 2020 to develop the world's first therapeutic that regenerates natural human teeth. The company's lead and only clinical asset is TRG035, a humanized monoclonal antibody that neutralizes USAG-1 (Uterine Sensitization-Associated Gene-1), a protein that normally inhibits tooth bud development; by blocking USAG-1, TRG035 is intended to reactivate dormant tooth buds and induce the growth of new natural teeth. The technology originated from over two decades of basic research by co-founder and CTO Dr. Katsu Takahashi at Kyoto University Graduate School of Medicine, with proof-of-concept demonstrated in animal models (mice, ferrets, dogs) and published in Science Advances in 2021.
The company's initial therapeutic focus is severe congenital partial anodontia (先天性無歯症), a rare genetic condition where patients lack permanent tooth buds. TRG035 received Japan MHLW Orphan Drug designation in September 2025, completed domestic Phase I clinical trials without serious adverse events, and is now preparing for Phase II trials in Japan while concurrently advancing US clinical development following a successful US FDA Pre-IND meeting in November 2025. The stated longer-term ambition is to expand the same mechanism into acquired tooth loss (cavities, periodontal disease, trauma) and elderly oral frailty, addressing a potential Japanese patient population of approximately 3 million.
Toregem generates no commercial revenue; the company is funded entirely by equity financing and government/non-dilutive grants. Cumulative funding including subsidies reached approximately JPY 4.6 billion (USD 29 million) as of May 2026, with a Pre-Series C round of JPY 850 million (USD 5.3 million) led by JIC Venture Growth Investments. The company employs 13 people as of April 2026 and operates from Kyoto, Japan. The GTM motion is sales-led to medical institutions via investigator-initiated clinical trials, with future commercial distribution planned through standard pharmaceutical channels upon regulatory approval.
Toregem BioPharma firmographics
Firmographics- Name
- Toregem BioPharma
- Legal name
- トレジェムバイオファーマ株式会社
- Website
- https://toregem.co.jp
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Toregem BioPharma is a Kyoto University spin-off developing TRG035, a humanized anti-USAG-1 antibody designed to regenerate natural teeth in patients with congenital edentulism. The clinical-stage biotech is preparing Phase II trials in Japan and US clinical entry, targeting rare genetic tooth agenesis first.
- Ownership category
- akta.pro rank
Toregem BioPharma industry classification
Industry- Product category
- Regenerative Biopharmaceuticals
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Offices of Dentists (62121), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Periodontal Regeneration (GTR/EMD/Biologics) (HLABACAI)
- akta.pro secondary industry
- Preventive & Routine General Dentistry (Exams/Cleanings/Sealants/Fluoride) (HLABAAAA)
Keywords
Where Toregem BioPharma is headquartered
LocationHeadquarters
- HQ city
- Kawaramachi
- HQ country
- Japan
- HQ region
- Asia
Offices1 record
Markets served
Toregem BioPharma business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Others
Revenue model
- Tooth Regeneration Drug Development and Commercialization: Pre-revenue biopharmaceutical company developing a novel tooth regeneration treatment (TRG035). Revenue will be generated through product sales upon successful clinical development and regulatory approval.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels7 records
Toregem BioPharma product offering
Product offeringCore offering
Toregem BioPharma is developing TRG035, a humanized anti-USAG-1 neutralizing monoclonal antibody that suppresses the USAG-1 protein, which normally inhibits tooth bud growth, thereby enabling patients' own dormant tooth buds to develop into natural teeth. The lead indication is congenital edentulism (congenital tooth agenesis), with future expansion planned to acquired tooth loss and oral frailty in the elderly; the product is currently advancing through Phase II clinical trials in Japan and pre-IND regulatory engagement with the US FDA.
Product overview
Toregem BioPharma is developing a single core product: TRG035, a humanized anti-USAG-1 antibody drug for tooth regeneration. The company is pursuing clinical development of this first-in-class regenerative antibody therapeutic, initially targeting congenital edentulism (congenital tooth agenesis), with plans to eventually expand to acquired tooth loss and oral frailty in the elderly. The product works by suppressing the USAG-1 protein that inhibits tooth bud growth, allowing new natural teeth to develop.
Differentiator
Problem solved
Functional benefit
Products and services
- TRG035 (Anti-USAG-1 Antibody) A humanized anti-USAG-1 neutralizing monoclonal antibody drug designed to suppress the USAG-1 protein that inhibits tooth bud growth, enabling patients' own dormant tooth buds to develop into natural teeth. Intended for congenital edentulism (initial indication) and planned expansion to acquired tooth loss; administered as a single injection. Currently in Phase II clinical development in Japan with parallel US FDA Pre-IND engagement.
Quantifiable outcome
- Phase I clinical trials at Kyoto University Hospital completed without serious adverse events
- +2 more outcomes
Companies that use Toregem BioPharma
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles3 records
Toregem BioPharma technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
Toregem BioPharma partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and supporting.
- 京都大学 (Kyoto University)coreTechnology origin - company founded based on research from Kyoto University Graduate School of Medicine, Department of Oral and Maxillofacial Surgery led by Dr. Katsu Takahashi.
- 公益ражение田附興風会医学研究所北野病院 (Kitano Hospital, Tazuke Kofukai Medical Research Institute)coreClinical trial partner conducting investigator-initiated clinical trials for tooth regeneration treatment. Dr. Takahashi serves as Chief of Oral and Maxillofacial Surgery.
- 東北大学東北リカール・メガバンク機構 (Tohoku University Tohoku Medical Megabank Organization)supportingResearch collaboration for early elucidation of hospital and pathology of congenital edentulism.
Scale indicators9 records
Recent moves7 records
Expansion highlights5 records
Toregem BioPharma competitors and assessment
Company assessmentEmerging players
- Stemmatters: Portugal-based regenerative medicine and cell therapy CDMO with dental/cartilage applications. Comparable as an emerging regenerative medicine peer with similar pre-commercial stage and tissue regeneration focus.
- Mesoblast: Australia-listed clinical-stage regenerative medicine company developing cellular therapies. Comparable as a peer regenerative-medicine developer pursuing novel mechanism-driven therapies with similar regulatory and commercialization risk profile.
- Pluristem Therapeutics: Israel-based clinical-stage cell therapy company in regenerative medicine. Comparable as a small-cap clinical regenerative medicine company facing similar Phase II/III execution risk and capital-raising dynamics.
- Cerapedics: US-based clinical-stage biotech developing peptide-based bone and dental regeneration therapeutics (i-FACTOR). Comparable as a small clinical-stage company commercializing novel biologic mechanisms for dental/oral tissue regeneration.
Broad incumbents
- BioHorizons: Global dental implant and regenerative products company (Henry Schein subsidiary). Comparable as an established player in the dental regeneration space offering alternative solutions to natural tooth regrowth.
- Straumann Group: Swiss-listed global leader in dental implants and tooth replacement. Most relevant dental-industry incumbent that Toregem's tooth regeneration drug would disrupt long-term.
- Dentsply Sirona: Largest global manufacturer of dental equipment, technologies, and consumables. Broad incumbent in dental solutions whose existing implant and prosthetic offerings are the incumbent alternative to Toregem's therapy.
- Astellas Pharma: Japan-listed global pharmaceutical company with deep regenerative medicine presence (acquired Ocata). Already an investor in Toregem via Astellas Venture Management and a likely strategic acquirer of clinical-stage regenerative assets.
Regional players
- AnGes MG: Japan-listed clinical-stage biopharmaceutical company developing gene and regenerative therapies. Comparable as a Japan-domiciled clinical-stage biotech with similar regulatory pathway (PMDA), capital structure, and commercialization dynamics.
- Takara Bio: Japan-listed biotechnology company with cell and gene therapy capabilities. Comparable as a Japanese biotech peer operating in regenerative medicine, sharing the PMDA regulatory pathway and Japanese investor ecosystem.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks7 records
Key highlights8 records
Customer concentration
Toregem BioPharma social profiles
Digital presenceToregem BioPharma compliance and trust
Trust signalCompliance1 record
Toregem BioPharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
Toregem BioPharma leadership team
Management profileNumber of profiles
Profiles7 records
Toregem BioPharma funding detail
Funding detailFunding overview
Funding rounds6 records
Investors12 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Toregem BioPharma M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Toregem BioPharma
What does Toregem BioPharma do?
Toregem BioPharma is developing TRG035, a humanized anti-USAG-1 neutralizing monoclonal antibody that suppresses the USAG-1 protein, which normally inhibits tooth bud growth, thereby enabling patients' own dormant tooth buds to develop into natural teeth. The lead indication is congenital edentulism (congenital tooth agenesis), with future expansion planned to acquired tooth loss and oral frailty in the elderly; the product is currently advancing through Phase II clinical trials in Japan and pre-IND regulatory engagement with the US FDA.
Is Toregem BioPharma a public or private company?
Toregem BioPharma is a private company. It is classified as venture growth investor backed and is currently operating.
When was Toregem BioPharma founded?
Toregem BioPharma was founded in 2020. It employs 1 to 10 people.
Where is Toregem BioPharma based?
Toregem BioPharma is headquartered in Kawaramachi, Japan, in the Asia region.
How does Toregem BioPharma make money?
One revenue line is on record: tooth Regeneration Drug Development and Commercialization.
Who are Toregem BioPharma's main competitors?
Emerging players on record are Stemmatters, Mesoblast, Pluristem Therapeutics and Cerapedics. Broad incumbents are BioHorizons, Straumann Group, Dentsply Sirona and Astellas Pharma. Regional players are AnGes MG and Takara Bio.
Does Toregem BioPharma have an API?
No public API is recorded for Toregem BioPharma.
What industry is Toregem BioPharma in?
Toregem BioPharma's product category is Regenerative Biopharmaceuticals. Its primary akta.pro industry code is HLABACAI, Periodontal Regeneration (GTR/EMD/Biologics), with a secondary code of HLABAAAA, Preventive & Routine General Dentistry (Exams/Cleanings/Sealants/Fluoride). Its NAICS code is 325414 and its SIC code is 2836.