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RP-G28
RP-G28 is a Microbiome modulator Small molecule drug developed by Ritter Pharmaceuticals, Inc.. It is currently in Phase 3 development for Hyperammonemia in urea cycle disorder patients. Also known as: galactic-oligosaccharide.
RP-G28 is a non-systemic oral therapeutic that modulates the gut microbiome to improve metabolic and immune function.
RP-G28 is a treatment being studied for lactose intolerance in a Phase 3 clinical trial. The trial, NCT03597516, is evaluating the efficacy, durability, safety, and tolerability of RP-G28 compared to a placebo in patients with lactose intolerance.
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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).
| 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 | RP-G28 |
|---|---|
| Also known as | galactic-oligosaccharide |
| Sponsor | Ritter Pharmaceuticals, Inc. |
| Drug class | Microbiome modulator |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Metabolic Disease |
| Phase | Phase 3 |
Mechanism of action
RP-G28 works by selectively promoting the growth of beneficial commensal bacteria in the gastrointestinal tract, thereby restoring a healthier microbiome composition. This microbiome modulation is intended to improve intestinal barrier function, reduce systemic inflammation, and enhance metabolic parameters without requiring systemic absorption of the drug itself.
Approved indications
- Hyperammonemia in urea cycle disorder patients
Common side effects
- Gastrointestinal symptoms (bloating, gas, diarrhea)
- Abdominal discomfort
Key clinical trials
- Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance (PHASE3)
- Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects (PHASE1)
- Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance (PHASE2, PHASE3)
- Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance (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:
- RP-G28 CI brief — competitive landscape report
- RP-G28 updates RSS · CI watch RSS
- Ritter Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about RP-G28
What is RP-G28?
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Is RP-G28 also known as anything else?
What drug class is RP-G28 in?
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Related
- Drug class: All Microbiome modulator drugs
- Manufacturer: Ritter Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Metabolic Disease
- Indication: Drugs for Hyperammonemia in urea cycle disorder patients
- Also known as: galactic-oligosaccharide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing