Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.

The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in estrogen receptor positive (ER+) breast cancer and vasomotor symptoms in postmenopausal women. Radius is also developing RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone receptor positive breast cancer.

Our Investigational Product Candidates

The following table identifies the investigational product candidates in our current product portfolio, their proposed indication and stage of development:


Preclinical


Phase 1


Phase 2


Phase 3

Regulatory
Review

Investigational drug product candidate abaloparatide-SC

Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe.

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Investigational drug product candidate abaloparatide-TD

We are developing abaloparatide-TD, based on 3M’s patented Microstructured Transdermal System technology, for potential use as a short wear-time transdermal patch for the treatment of postmenopausal women with osteoporosis. We commenced a human replicative clinical evaluation of the optimized abaloparatide-TD patch with the goal of achieving comparability to abaloparatide-SC. The results of this ongoing clinical evaluation will inform the design of a pivotal bioequivalence study that will be initiated following completion of activities related to manufacturing scale-up, production, and other activities required for the initiation of that study.

Investigational drug product candidate elacestrant

Elacestrant is a selective estrogen receptor down-regulator/degrader, or SERD, that at high doses is being evaluated for potential use as an oral non-steroidal treatment for estrogen receptor positive (ER+) breast cancer. Elacestrant is currently being investigated as a single agent in postmenopausal women with advanced ER+ and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most common form of the disease. Preclinical studies completed to date indicate that the compound also has the potential for use in combination with other therapies for the treatment of breast cancer.

Clinical Trials

A Phase IB Study to Evaluate the Effect of RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

Investigational drug product candidate elacestrant

Elacestrant is also being evaluated at low doses for the potential reduction of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms.

Clinical Trial

Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

Investigational drug product candidate RAD140

RAD140 is a nonsteroidal selective androgen receptor modulator, or SARM, which resulted from an internal discovery program. The androgen receptor, or AR, is highly expressed in many ER-positive, ER-negative, and triple-negative receptor breast cancers. An investigational new drug application, or IND, submitted to the FDA has been accepted. We expect to initiate a first-in-human Phase 1 clinical trial in postmenopausal women with hormone receptor positive breast cancer in 2017.

Clinical Trial

A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer