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Ramycin (FUSIDIC ACID)
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.
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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.
| 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 name | FUSIDIC ACID |
|---|---|
| Drug class | fusidic acid |
| Target | Bile salt export pump |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 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
- Acne vulgaris
- Actinomycotic infection
- Acute bacterial sinusitis
- Acute gonococcal cervicitis
- Acute gonococcal endometritis
- Acute gonococcal epididymo-orchitis
- Acute gonococcal urethritis
- Allergic conjunctivitis
- Anterior uveitis
- Anthrax
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial infection due to Serratia
- Bacterial infection of skin
- Bacterial keratitis
- Bacterial meningitis
- Bacterial peritonitis
- Bacterial pneumonia
- Bacterial septicemia
- Bacterial urinary infection
Common side effects
- Spontaneous ecchymoses
- Erysipelas
- Boil
- Perioral dermatitis
- Bacterial folliculitis
- Dermatophytosis
- Paronychia
- Actinic keratosis
- Urticaria acuta
- Dysesthesia of the skin
- Deep bacterial inflammation in the subcutaneous tissue
- Hidrosadenitis suppurativa
Drug interactions
- CYP3A4 Substrates
Key clinical trials
- Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis (PHASE3)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2) (PHASE3)
- Fucidin® Cream in the Treatment of Impetigo (PHASE4)
- Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema (PHASE3)
- Efficacy of 100% Trichloroacetic Acid Vs. Cryotherapy in Xanthelasma Palpebrarum (NA)
- Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia (PHASE3)
- M. Hailey-Hailey: hSPCA1 Expression and Skin Structure Upon Laser Therapy (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 |
|---|---|
| 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:
- Ramycin CI brief — competitive landscape report
- Ramycin updates RSS · CI watch RSS
Frequently asked questions about Ramycin
What is Ramycin?
How does Ramycin work?
What is Ramycin used for?
What is the generic name of Ramycin?
What drug class is Ramycin in?
What development phase is Ramycin in?
What are the side effects of Ramycin?
What does Ramycin target?
Related
- Drug class: All fusidic acid drugs
- Target: All drugs targeting Bile salt export pump
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acne vulgaris
- Indication: Drugs for Actinomycotic infection
- Indication: Drugs for Acute bacterial sinusitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing