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Ketoacid
Ketoacid is a Small molecule drug developed by RSUP Fatmawati. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Ketoacid |
|---|---|
| Sponsor | RSUP Fatmawati |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Application site pain
- Application site erythema
- Application site pruritus
- Application site oedema
- Application site paraesthesia
- Application site scab
- Application site induration
- Application site discharge
- Application site exfoliation
- Application site erosion
- Nasopharyngitis
- Application site vesicles
Key clinical trials
- Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions (PHASE2)
- Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma (PHASE2)
- A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF) (PHASE2)
- Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3 (PHASE4)
- Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA） (PHASE3)
- Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (PHASE3)
- Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401) (PHASE1)
- 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (EARLY_PHASE1)
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:
- Ketoacid CI brief — competitive landscape report
- Ketoacid updates RSS · CI watch RSS
- RSUP Fatmawati portfolio CI
Frequently asked questions about Ketoacid
What is Ketoacid?
Who makes Ketoacid?
What development phase is Ketoacid in?
What are the side effects of Ketoacid?
Related
- Manufacturer: RSUP Fatmawati — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing