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Low Dose Maolactin
Low Dose Maolactin is a macrolide antibiotic Small molecule drug developed by RDC Clinical Pty Ltd. It is currently in Phase 3 development for Community-acquired pneumonia, Acute exacerbations of chronic bronchitis, Acute bacterial sinusitis.
Low Dose Maolactin is a derivative of erythromycin that works by inhibiting bacterial protein synthesis.
Low Dose Maolactin is a derivative of erythromycin that works by inhibiting bacterial protein synthesis. Used for Community-acquired pneumonia, Acute exacerbations of chronic bronchitis, Acute bacterial sinusitis.
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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 | Low Dose Maolactin |
|---|---|
| Sponsor | RDC Clinical Pty Ltd |
| Drug class | macrolide antibiotic |
| Target | 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious diseases |
| Phase | Phase 3 |
Mechanism of action
It achieves this by binding to the 50S ribosomal subunit of bacteria, thereby preventing the formation of peptide bonds and ultimately inhibiting bacterial growth. This action is specific to bacteria and does not affect human cells.
Approved indications
- Community-acquired pneumonia
- Acute exacerbations of chronic bronchitis
- Acute bacterial sinusitis
Common side effects
- Nausea
- Vomiting
- Abdominal pain
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.
| 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:
- Low Dose Maolactin CI brief — competitive landscape report
- Low Dose Maolactin updates RSS · CI watch RSS
- RDC Clinical Pty Ltd portfolio CI
Frequently asked questions about Low Dose Maolactin
What is Low Dose Maolactin?
How does Low Dose Maolactin work?
What is Low Dose Maolactin used for?
Who makes Low Dose Maolactin?
What drug class is Low Dose Maolactin in?
What development phase is Low Dose Maolactin in?
What are the side effects of Low Dose Maolactin?
What does Low Dose Maolactin target?
Related
- Drug class: All macrolide antibiotic drugs
- Target: All drugs targeting 50S ribosomal subunit
- Manufacturer: RDC Clinical Pty Ltd — full pipeline
- Therapeutic area: All drugs in Infectious diseases
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Acute exacerbations of chronic bronchitis
- Indication: Drugs for Acute bacterial sinusitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing