Pipeline

pipeline status

Abaloparatide-SC
Being Developed For Osteoporosis
Subcutaneous Injection
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Investigational drug product candidate Abaloparatide-SC

BA058-SCAbaloparatide is a new synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein), a naturally occurring bone building hormone. PTHrP, unlike parathyroid hormone, is critical in the formation of the skeleton, is involved in the regulation of bone formation, and is able to rebuild bone with low associated risk of inducing hypercalcemia as a side effect.

In a Phase 2 clinical trial, the investigational drug product candidate abaloparatide was administered through a subcutaneous injection (Abaloparatide-SC) and produced faster and greater bone mineral density increases at the spine and the hip, with substantially less hypercalcemia than Forteo® (teriparatide). The clinical significance of these initial findings is being investigated in an ongoing Phase III clinical trial, and all the resulting data are subject to regulatory review.

Abaloparatide-TD
Being Developed For Osteoporosis
Transdermal Patch
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Investigational drug product candidate Abaloparatide-TD

applicatorpatch1 Results of a Phase 2 clinical trial provided initial evidence of efficacy, safety, and tolerability of Abaloparatide-TD in the potential treatment of osteoporosis. At each dose, Abaloparatide-TD demonstrated a statistically significant mean percent increase from baseline in bone mineral density (BMD) as compared to placebo at the lumbar spine and at the hip. These clear, proof-of-concept results indicated a dose-dependent increase in BMD. The clinical significance of these initial findings must be investigated in subsequent clinical trials, and all the resulting data are subject to regulatory review.

For patients with BCBM, there currently are no approved targeted therapies that cross the blood-brain barrier. Radius believes there could be a potential opportunity for RAD1901, if successfully developed and approved following regulatory review, to become the first ER-targeted therapy that crosses the blood-brain barrier if it were to demonstrate the ability to more effectively treat ER-positive BCBM and potentially reduce both intracranial and extracranial BCBM tumors.

RAD1901
Being Developed For Breast Cancer Brain Metastases
Oral
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Investigational drug product candidate RAD1901

RAD1901 is a selective estrogen receptor down-regulator/degrader, or SERD, that crosses the blood-brain barrier and is being evaluated for the potential treatment of breast cancer brain metastases (BCBM). Data from very early stages of development indicate that RAD1901 binds with good selectivity to the estrogen receptor and has both estrogen-like and estrogen-antagonistic effects in different tissues. The clinical significance of these initial findings must be investigated in clinical trials, and all the resulting data are subject to regulatory review. In many cancers, hormones, like estrogen, stimulate tumor growth, and thus a desired therapeutic goal is to block this estrogen-dependent growth while inducing apoptosis of the cancer cells. SERDs have the potential to be an emerging class of endocrine therapies that could directly induce estrogen receptor, or ER, degradation, thus potentially enabling them to remove the estrogen growth signal in ER-dependent tumors without allowing ligand-independent resistance to develop. For patients with BCBM, there currently are no approved therapies that cross the blood-brain barrier. Radius believes there could be a potential opportunity for RAD1901, if successfully developed and approved following regulatory review, to become the first ER-targeted therapy that crosses the blood-brain barrier if it were to demonstrate the ability to more effectively treat ER-positive BCBM and potentially reduce both intracranial and extracranial BCBM tumors.

RAD1901
Being Developed For Vasomotor Symptoms
Oral
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Investigational drug product candidate RAD1901

RAD1901 is in development at lower doses as a selective estrogen receptor modulator, or SERM, for the potential treatment of vasomotor symptoms. In a Phase 2 proof-of-concept study, RAD1901 demonstrated a reduction in frequency and severity of moderate and severe hot flashes. The clinical significance of these initial findings must be investigated in subsequent clinical trials, and all the resulting data are subject to regulatory review.

RAD140
Being Developed For Cachexia / Frailty / Breast Cancer
Oral
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Investigational drug product candidate RAD140

RAD140 is a nonsteroidal selective androgen receptor modulator, or SARM, which is an orally active androgen agonist on muscle and bone. Data from preclinical studies suggest that RAD140 has potent anabolic activity on muscle and bone. The clinical significance of these initial findings must be investigated in clinical trials, and all the resulting data are subject to regulatory review. Because of its potential high anabolic efficacy, receptor selectivity, potent oral activity, and long duration half-life, RAD140 could have clinical potential in a number of indications where the increase in lean muscle mass and/or bone density is beneficial, such as potentially treating the weight loss due to cancer cachexia, muscle frailty and osteoporosis, and breast cancer.

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