Last reviewed · How we verify

Ramycin (FUSIDIC ACID)

Phase 3 active Small molecule Quality 47/100

Ramycin (generic name: FUSIDIC ACID) is a fusidic acid drug. It is currently in Phase 3 development for Acne vulgaris, Actinomycotic infection, Acute bacterial sinusitis.

Fusidic acid works by inhibiting the function of the bacterial ribosome, preventing the production of essential proteins.

Likelihood of approval
60.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Anti-infectives pathway favourability +2.0pp
    Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameFUSIDIC ACID
Drug classfusidic acid
TargetBile salt export pump
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 3

Mechanism of action

Imagine your body's cells are like factories that make proteins to keep you healthy. Fusidic acid is like a key that locks the factory door, stopping the bacteria from making the proteins they need to survive and multiply.

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ramycin

What is Ramycin?

Ramycin (FUSIDIC ACID) is a fusidic acid drug, indicated for Acne vulgaris, Actinomycotic infection, Acute bacterial sinusitis.

How does Ramycin work?

Fusidic acid works by inhibiting the function of the bacterial ribosome, preventing the production of essential proteins.

What is Ramycin used for?

Ramycin is indicated for Acne vulgaris, Actinomycotic infection, Acute bacterial sinusitis, Acute gonococcal cervicitis, Acute gonococcal endometritis.

What is the generic name of Ramycin?

FUSIDIC ACID is the generic (nonproprietary) name of Ramycin.

What drug class is Ramycin in?

Ramycin belongs to the fusidic acid class. See all fusidic acid drugs at /class/fusidic-acid.

What development phase is Ramycin in?

Ramycin is in Phase 3.

What are the side effects of Ramycin?

Common side effects of Ramycin include Spontaneous ecchymoses, Erysipelas, Boil, Perioral dermatitis, Bacterial folliculitis, Dermatophytosis.

What does Ramycin target?

Ramycin targets Bile salt export pump and is a fusidic acid.

Related

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