FAQ & Glossary
Questions and
terms.
Answers to the questions we are asked most often about Novelglue (FP-121), based on the primary data published across this site.
Development stage: the medical application data on this page are all from preclinical (animal and in vitro) studies. FP-121 is an investigational material and has not been approved as a medical device or regenerative medical product. Efficacy and safety in humans have not been established.
Frequently Asked Questions
Frequently asked questions
- 01
What is Novelglue (FP-121)?
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A recombinant adhesive protein designed after fp-1, a mussel foot protein. It bonds in wet environments while also promoting cell adhesion and proliferation. It is developed by Novelgen Co., Ltd. FP-121 is the molecule; Novelglue is the technology and product family.
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What is its molecular architecture?
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FP1–FP2–FP1: adhesive domains at both termini and one functional domain in the middle, approximately 27 kDa, expressed recombinantly in E. coli. The central FP2 acts as a swappable cassette, so functions such as EGF activity or targeting peptides can be fused in.
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Why can it bond on a wet surface?
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The FP1 domains at both termini interact with hydroxyl (–OH), amino (–NH₂), carboxyl (–COOH) and sulfo (–SO₃H) groups on tissue. Unlike conventional adhesives that must displace water, it is designed for conditions where water is present. An optional Tyr→DOPA modification adds metal-ion coordination when more grip is needed.
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How strong is the adhesion?
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63 kPa tensile strength in saline — roughly 30x fibrin glue, which delivers 2–5 kPa in a wet field. It is designed to perform under surgical conditions including blood, marrow and synovial fluid.
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How does it differ from fibrin glue?
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In strength and in origin. 63 kPa versus 2–5 kPa. Fibrin glue is derived from human plasma, which brings patient consent requirements and supply constraints; Novelglue is produced recombinantly in E. coli, so viral and prion transmission risk does not exist in principle and no consent form is needed. It is also stable for 12 months at ambient temperature, light-protected.
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How does it differ from PMMA bone cement?
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Chiefly the polymerisation exotherm. PMMA exceeds 70°C during curing and, together with residual MMA cytotoxicity, raises the risk of local necrosis. Novelglue has no polymerisation exotherm and is based on a biocompatible protein, so osteoblast activity is not suppressed. In AMED-backed rat femur studies, bone formation filled the groove by week 3 and cortical bone regenerated by week 5.
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Does it use animal-derived materials?
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No. It is produced recombinantly in E. coli and is animal-free. This avoids the lot-to-lot variation of Matrigel (mouse EHS sarcoma) and the individual-animal and pathogen risks of natural mussel extracts. It aligns with the FDA Modernization Act 2.0 and PMDA animal-free trends.
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How far has safety been established?
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Of the ISO 10993 biological safety package, five items are complete: cytotoxicity (IC50 1.08 ± 0.30 mg/mL), genotoxicity, hemolysis, irritation and implantation. Sensitization is in progress and degradation is planned. Estimated LD50 is 1.41 g/kg, a margin of about 2,100x over the intended dose. These are research-grade results; regulatory filing requires repetition under GLP.
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Is it approved as a medical device or drug?
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No. Novelglue (FP-121) is an investigational material at the preclinical stage. All medical application data on this site are from animal or in vitro studies. Efficacy and safety in humans have not been established. First-in-Human is targeted for 2028 or later.
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What were the meniscus study results?
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In joint research with the Department of Orthopaedic Surgery, Kagawa University, a rabbit medial meniscus longitudinal tear model (5 mm in the anterior white–white zone) was used. A group receiving 20 mg of FP-121 plus two vertical mattress sutures was compared with a suture-only group, six knees each, evaluated at 12 weeks. The histological healing rate was 50.1 ± 25.3% with FP-121 versus 8.3 ± 20.4% with suture alone (paired t-test, p = 0.025), and bridging was seen in 5 of 6 knees versus 1 of 6. These are preclinical results.
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How do NovelMatrix, NovelGlue and NovelDDS differ?
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Three products from the same cassette platform. NovelMatrix is a cell culture substrate that keeps suspension cells adherent while they proliferate. NovelGlue is a bone, cartilage and dental adhesive that also forms a bone putty when compounded with β-TCP. NovelDDS turns the adhesive itself into a drug carrier and is currently at the design stage.
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As a culture substrate, how does it differ from Matrigel?
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In origin and reproducibility. Matrigel is a natural extract from mouse EHS sarcoma, with high lot-to-lot variation and difficult GMP compliance. NovelMatrix is fully recombinant, with high lot reproducibility and a clear GMP path. It also holds suspension cells in an adherent state, reduces exogenous EGF in the media through the EGF cassette, and allows enzyme-free detachment that preserves surface antigens.
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What are the storage and shipping conditions?
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Stable for 12 months at ambient temperature, light-protected. No cold chain is required. It is used by adding one vial to an existing surgical procedure, with no dedicated instruments and no cell-handling facilities.
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What is the IP position?
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The core patent, "Recombinant protein with adhesive and functional properties, and compositions containing it", was filed as JP 2023-030567 (28 February 2023) and PCT/JP2024/007452. Composition-of-matter patents have entered national phase in Japan, the US and Europe, and a use patent covering meniscal adhesion is filed. The portfolio is built in four layers: composition, method of use, manufacturing and formulation.
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Is there third-party validation or public funding?
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Yes. The technology is supported by AMED translational research grants: seed H (2025–26) at Kyoto University for bone adhesion, and seed A (2025–26) hosted by the Hokkaido University hub, with Prof. Masakazu Ishikawa at Kagawa University covering the meniscus. The underlying work is published in Materials & Design (Kawakami Y et al., 2025;255:114153). Other recognition includes NEDO venture support (2018), selection for Toyo Keizai's Top 100 Ventures (2025) and the HVC KYOTO 2023 Kansai Innovation Initiative Award.
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What is the timeline to clinical trials and market?
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Three phases. Phase 1 (2026): test-article specification and PMDA consultation. Phase 2 (2027): the GLP ISO 10993 safety package and large-animal PoC in sheep and pigs. Phase 3 (2028+): investigator-led trials at Kagawa and Kyoto moving to company-sponsored trials, filing in Japan, then Europe (CE / MDR), then the United States (FDA). This is the current plan, not a fixed schedule.
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Who should we contact about joint research or evaluation?
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Please use the contact form or write to office@novelgen.jp. Enquiries on joint research, licensing, investment and product evaluation are all welcome, and we prepare materials appropriate to the stage of the discussion.
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Glossary
Glossary
Definitions for the concepts used across this site.
- FP-121
- The molecular designation of Novelglue: a recombinant protein of approximately 27 kDa with an FP1–FP2–FP1 three-domain architecture, expressed in E. coli.
- Mussel foot protein (MFP)
- The family of proteins making up the byssus that mussels secrete to anchor to rock. Six are known, fp-1 through fp-6, with fp-1 regarded as central to adhesion in wet environments. Novelglue is inspired by fp-1.
- DOPA (3,4-dihydroxyphenylalanine)
- An amino acid formed by hydroxylation of tyrosine. Its catechol group forms metal-ion coordination, hydrogen bonds and π-interactions, contributing to adhesion in wet environments. In FP-121 it can be introduced as an optional post-modification.
- Cassette design
- The design principle of treating the central FP2 domain of FP-121 as a swappable slot. Fusing in an EGF-like domain, osteogenic motifs, antimicrobial peptides or targeting peptides lets one platform yield application-specific derivatives.
- White–white zone
- The inner, avascular region of the meniscus. With no blood supply, a sutured tear there heals with almost no biological support, so partial meniscectomy has often been chosen instead. The meniscus is zoned from the periphery inward as red-red, red-white and white-white.
- Animal-free
- Using no animal-derived materials in the manufacturing process. This avoids transmission risk from viruses and prions, and the lot-to-lot variation that comes from individual animal sources. It is an increasingly important requirement in regenerative medicine regulation.
- ISO 10993
- The international standard series for the biological evaluation of medical devices, covering cytotoxicity, sensitization, irritation, genotoxicity, implantation, hemocompatibility and more. Regulatory filing requires the studies to be conducted under GLP.
- β-TCP (beta-tricalcium phosphate)
- A resorbable bone graft substitute with osteoconductive properties that is replaced by newly formed bone. Compounded with NovelGlue it forms a workable bone putty for filling bone voids.
- First-in-Human (FIH)
- The first study in which an investigational drug or device is administered to humans. For Novelglue this is targeted for 2028 or later, beginning with investigator-led trials at Kagawa and Kyoto Universities.
- AMED translational research programme
- A programme of the Japan Agency for Medical Research and Development (AMED) that supports translating academic research into practical application. It is staged into seeds such as A and H, and awards are made through host university hubs.