Isotonic fluid

Johns Hopkins University · Phase 3 active Small molecule

Isotonic fluid is a Crystalloid fluid / Intravenous fluid replacement Small molecule drug developed by Johns Hopkins University. It is currently in Phase 3 development for Fluid resuscitation in dehydration, Perioperative fluid management, Hypovolemic shock. Also known as: Normal saline, Lactated ringers solution, Dextrose normal saline.

Isotonic fluid restores intravascular volume and maintains osmotic balance to correct dehydration and electrolyte disturbances.

Isotonic fluid restores intravascular volume and maintains osmotic balance to correct dehydration and electrolyte disturbances. Used for Fluid resuscitation in dehydration, Perioperative fluid management, Hypovolemic shock.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• 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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Isotonic fluid
Also known as	Normal saline, Lactated ringers solution, Dextrose normal saline
Sponsor	Johns Hopkins University
Drug class	Crystalloid fluid / Intravenous fluid replacement
Modality	Small molecule
Therapeutic area	Critical Care / Emergency Medicine / Perioperative Medicine
Phase	Phase 3

Mechanism of action

Isotonic fluids (such as normal saline or balanced crystalloids) have an osmolarity matching plasma, allowing them to distribute between intravascular and interstitial compartments without causing cellular water shifts. They are used to restore circulating volume, maintain hemodynamic stability, and correct fluid deficits in dehydrated or critically ill patients. The specific formulation determines electrolyte composition and clinical suitability for different patient populations.

Approved indications

• Fluid resuscitation in dehydration
• Perioperative fluid management
• Hypovolemic shock
• Maintenance fluid therapy in hospitalized patients

Common side effects

• Hyperchloremic acidosis
• Fluid overload / pulmonary edema
• Hyponatremia (with excessive hypotonic fluid)
• Phlebitis at infusion site

Key clinical trials

• Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
• Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery (PHASE1)
• Volume Kinetics of Fluid Resuscitation in Early Sepsis
• Initial Resuscitation for Acute Kidney Injury in Cirrhosis (NA)
• Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications (PHASE4)
• Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PHASE3)
• Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions. (NA)
• Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis (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:

• Isotonic fluid CI brief — competitive landscape report
• Isotonic fluid updates RSS · CI watch RSS
• Johns Hopkins University portfolio CI

Frequently asked questions about Isotonic fluid

What is Isotonic fluid?

Isotonic fluid is a Crystalloid fluid / Intravenous fluid replacement drug developed by Johns Hopkins University, indicated for Fluid resuscitation in dehydration, Perioperative fluid management, Hypovolemic shock.

How does Isotonic fluid work?

Isotonic fluid restores intravascular volume and maintains osmotic balance to correct dehydration and electrolyte disturbances.

What is Isotonic fluid used for?

Isotonic fluid is indicated for Fluid resuscitation in dehydration, Perioperative fluid management, Hypovolemic shock, Maintenance fluid therapy in hospitalized patients.

Who makes Isotonic fluid?

Isotonic fluid is developed by Johns Hopkins University (see full Johns Hopkins University pipeline at /company/johns-hopkins-university).

Is Isotonic fluid also known as anything else?

Isotonic fluid is also known as Normal saline, Lactated ringers solution, Dextrose normal saline.

What drug class is Isotonic fluid in?

Isotonic fluid belongs to the Crystalloid fluid / Intravenous fluid replacement class. See all Crystalloid fluid / Intravenous fluid replacement drugs at /class/crystalloid-fluid-intravenous-fluid-replacement.

What development phase is Isotonic fluid in?

Isotonic fluid is in Phase 3.

What are the side effects of Isotonic fluid?

Common side effects of Isotonic fluid include Hyperchloremic acidosis, Fluid overload / pulmonary edema, Hyponatremia (with excessive hypotonic fluid), Phlebitis at infusion site.

Related

• Drug class: All Crystalloid fluid / Intravenous fluid replacement drugs
• Manufacturer: Johns Hopkins University — full pipeline
• Therapeutic area: All drugs in Critical Care / Emergency Medicine / Perioperative Medicine
• Indication: Drugs for Fluid resuscitation in dehydration
• Indication: Drugs for Perioperative fluid management
• Indication: Drugs for Hypovolemic shock
• Also known as: Normal saline, Lactated ringers solution, Dextrose normal saline