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hypotonic
hypotonic is a Small molecule drug developed by Hospital General de Niños Pedro de Elizalde. It is currently in Phase 1 development. Also known as: half saline/5% dextrose.
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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 | hypotonic |
|---|---|
| Also known as | half saline/5% dextrose |
| Sponsor | Hospital General de Niños Pedro de Elizalde |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Cervical Spine Focused Treatment for Patients With Persistent Concussion Symptoms and Neck Pain (NA)
- Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Management of Patients With Glaucomar or Ocular Hypertension and Concomitant Dry Eye Syndrome on Multiple Long-term Topical Hypotensive Therapy (NA)
- CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS (PHASE4)
- Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
- Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection
- Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment (PHASE4)
- Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia (PHASE3)
- 3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis (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:
- hypotonic CI brief — competitive landscape report
- hypotonic updates RSS · CI watch RSS
- Hospital General de Niños Pedro de Elizalde portfolio CI
Frequently asked questions about hypotonic
What is hypotonic?
Who makes hypotonic?
Is hypotonic also known as anything else?
What development phase is hypotonic in?
Related
- Manufacturer: Hospital General de Niños Pedro de Elizalde — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: half saline/5% dextrose
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing