What development phase is SPECTINOMYCIN HYDROCHLORIDE in?

SPECTINOMYCIN HYDROCHLORIDE is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

SPECTINOMYCIN HYDROCHLORIDE

FDA-approved approved Small molecule Quality 0/100

Spectinomycin Hydrochloride is a marketed antibiotic with a key composition patent expiring in 2028. Its primary strength lies in its established market presence and continued revenue generation. The primary risk is the potential increase in competition following the patent expiry in 2028.

At a glance

Generic name	SPECTINOMYCIN HYDROCHLORIDE
Modality	Small molecule
Phase	FDA-approved
First approval	1971

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
Michigan Stroke Transitions Trial (NA)

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
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
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:

SPECTINOMYCIN HYDROCHLORIDE CI brief — competitive landscape report
SPECTINOMYCIN HYDROCHLORIDE updates RSS · CI watch RSS