Last reviewed 2026-05-19 · How we verify

BA058 20 µg

Radius Health, Inc. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 0/100

BA058 20 µg is a Small molecule drug developed by Radius Health, Inc.. It is currently in Phase 2 development.

BA058 20 µg is a small molecule being studied in a Phase 2 clinical trial for the treatment of postmenopausal women with osteoporosis. The trial is a randomized, parallel-group dose-finding study comparing BA058 20 µg to teriparatide and placebo.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BA058 20 µg
Sponsor	Radius Health, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BA058 20 µg CI brief — competitive landscape report
BA058 20 µg updates RSS · CI watch RSS
Radius Health, Inc. portfolio CI

Frequently asked questions about BA058 20 µg

What is BA058 20 µg?

BA058 20 µg is a Small molecule drug developed by Radius Health, Inc..

Who makes BA058 20 µg?

BA058 20 µg is developed by Radius Health, Inc. (see full Radius Health, Inc. pipeline at /company/radius-health-inc).

What development phase is BA058 20 µg in?

BA058 20 µg is in Phase 2.

Manufacturer: Radius Health, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing