Pipeline Overview

Preclinical
Phase 1
Phase 2
Phase 3
Regulatory Review

Abaloparatide-SC

Anabolic Subcutaneous Injection

Men with osteoporosis

Current Status: Phase 3

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Phase 3

Investigational drug product candidate abaloparatide-SC

In 2018, we initiated a Phase 3 study (ATOM), assessing the efficacy and safety of abaloparatide injection for the treatment of osteoporosis in men. The randomized, double-blind, placebo-controlled trial enrolled a total of 228 men with osteoporosis. In October 2021, Radius announced positive topline results from the ATOM trial.

Preclinical
Phase 1
Phase 2
Phase 3
Regulatory Review

Abaloparatide-TD

Transdermal system

Postmenopausal women with osteoporosis

Current Status: Phase 3

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Phase 3

Investigational drug product candidate abaloparatide-TD

In August 2019, we initiated our Phase 3 wearABLe study of abaloparatide transdermal system (“abaloparatide-TD”), a single, pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study with a planned enrollment of approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The topline results were reported in December 2021.

Preclinical
Phase 1
Phase 2
Phase 3
Regulatory Review

Elacestrant (RAD1901)

Oral Tablet

ER+ breast cancer

Current Status: Phase 3

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Phase 3

Investigational drug product candidate elacestrant

Elacestrant is a selective estrogen receptor degrader (SERD) out-licensed to Menarini Group which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

In 2018 we initiated and opened for enrollment a Phase 3 study (EMERALD) evaluating elacestrant as second- or third-line monotherapy in postmenopausal women with advanced/metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients. The study achieved its enrollment target of 466 patients who have received prior treatment with one or two lines of endocrine therapy, including a cyclin-dependent kinase (CDK) 4/6 inhibitor. In October 2021, the Radius and Menarini group jointly announced positive topline results from the EMERALD trial.

Preclinical
Phase 1
Phase 2
Phase 3
Regulatory Review

Synthetic cannabidiol (RAD011)

Oral Solution

Seizures associated with Angelman syndrome (AS)



Hyperphagia associated with Prader-Willi syndrome (PWS)

Current Status: Phase 3

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Phase 3

Investigational drug product candidate RAD011

In 2021 Radius announced the acquisition of the global development and commercialization rights to RAD011, a synthetic cannabidiol (CBD) oral solution, from Benuvia Therapeutics Inc.

Over 125 patients have participated in clinical trials with RAD011 across multiple indications and a substantial nonclinical, clinical and safety data package to support advancement into pivotal programs. Radius plans to initiate global pivotal programs in Angelman syndrome (AS, Phase 3) by Q4 2022 and Prader-Willi syndrome (PWS, Phase 2/3) in Q2 2022. Both study designs are informed by existing botanical CBD data, RAD011 pre-existing data, literature and learnings from previous clinical programs.

RAD011 has been granted Orphan Drug Designation for AS (February 2022) and Fast Track Designation (2017) Orphan Drug Designation for PWS (August 2020).

Radius is committed to conducting clinical trials in a transparent manner.

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