Regulatory Status

Oncology

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ZetaMet™
ZetaMet™ is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone. The U.S. Food and Drug Administration recently awarded ZetaMet™ Breakthrough Device Designation for the treatment of metastatic bone cancer. Currently, ZetaMet™ has been approved by Health Canada for a clinical trial which is currently enrolling for the treatment of metastatic breast cancer lesions to the spine. Also, ZetaFuse® has been approved by the Human Research Ethics Committee in Australia for the treatment of Degenerative Disc Disease for the fusion of the cervical spine. Enrollment for this study is scheduled for Q1-2024.
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ZetaMet-P™
ZetaMet-P™ is a synthetic, small-molecule, antitumorigenic biologic technology being developed to target and resolve metastatic prostate cancer bone lesions while inhibiting future tumor growth. ZetaMet-P™ is administered via an outpatient percutaneous procedure directly to the lesion site. The small molecule has been approved by the U.S. Food and Drug Administration (FDA) since 1971. Zetagen scientists have discovered an entirely new pathway for this established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for patients living with metastatic prostate cancer bone lesions.
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ZetaMAST™
ZetaMAST™ is a novel drug being designed for patients with unresectable, multifocal breast cancer metastases to the liver, lung, or brain. ZetaMAST™ can be administered as a single, percutaneous injection utilizing a proprietary hydrogel carrier containing a precise, tailored concentration of our small molecule. Preclinical studies have demonstrated ZetaMAST™ may cease lesion growth, with the goal of enabling improved quality of life as part of a cancer treatment program, including longevity.

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ZetaOnc™
Settable
ZetaOnc™ Settable is the Next Generation Bone Cement which will provide significant benefits to clinicians treating patients with imminent risk of Skeletal Related Event (SRE) / fracture of the vertebral body or bone contributed from a metastatic lytic lesion. ZetaOnc™ is resorbable, antitumorigenic, osteoinductive, hemostatic and has the same modulus of elasticity as healthy bone. It has a superior safety profile (e.g., no toxicity and material curing is isothermic).

ZetaOnc™ Settable is made possible by the discovery of a NEW chemical entity coupled with Zetagen’s existing bone healing product that is focused on delivering a well-known small molecule to the wound site via a proprietary biologic carrier.

ZetaOnc™ will integrate with adjacent bone, grow new bone, inhibit future tumor growth, and once healed will not cause an adjacent fracture.

Musculoskeletal

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ZetaFuse™
ZetaFuse™ is the first synthetic, small molecule, osteo-inductive biologic, to safely aid bone healing of spinal fusions. The FDA has awarded ZetaFuse™ Breakthrough Device Designation[1] for the complete spinal column. 
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ZetaSet™
ZetaSet™ is the first synthetic, osteo-inductive, biologic designed specifically for the treatment of osteoporotic fractures, high energy injuries with bone defects, and for patients with fractures of the tibial plateau (knee) and plafond (ankle).
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ZetaBase®
ZetaBase® is an osteo-conductive and osteo-promotive therapy, intended for the use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pending 510K approval 2H-2022.  

Craniomaxillofacial

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ZetaDent™
ZetaDent™ is an osteo-inductive biologic intended to promote bone formation as a part of localized ridge augmentation procedures prior to dental implant placement, alveolar ridge reconstruction procedures for prosthetic treatment, and for filling of bone defects in the oral cavity.
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ZetaSet™
ZetaSet™ is the first synthetic, osteo-inductive, biologic designed specifically for the treatment of osteoporotic fractures, high energy injuries with bone defects, and for patients with fractures of the tibial plateau (knee) and plafond (ankle).

Clinical Trials

Pending FDA/HC Spine Met Tumor Study Scheduled Q1 2024