TheraRadar
Data updated: May 26, 2026

TROMETHAMINE

Other Approved 2024-12-09

TROMETHAMINE is indicated for the treatment of Metabolic Acidosis; Cardiac Arrest.

Source: FDA Label • B BRAUN MEDICAL
2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-12-09
Routes
INJECTION
Dosage Forms
SOLUTION

Companies

Active Ingredient: TROMETHAMINE

TROMETHAMINE Approval History

2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2024
Dec 2024 ORIGINAL
Update
Dec 2024 ORIGINAL
Update

What TROMETHAMINE Treats

2 indications

TROMETHAMINE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metabolic Acidosis
  • Cardiac Arrest
Source: FDA Label

TROMETHAMINE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TROMETHAMINE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SODIUM BICARBONATE
SODIUM BICARBONATE
2 shared
Pfizer
Shared indications:
Metabolic AcidosisCardiac Arrest
THAM
TROMETHAMINE
2 shared
Pfizer
Shared indications:
Metabolic AcidosisCardiac Arrest
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TROMETHAMINE FDA Label Details

Indications & Usage

TROMETHAMINE is indicated for the treatment of Metabolic Acidosis; Cardiac Arrest.

Looking for the branded version?

THAM

Full clinical data, patents, trials, and competitive landscape for tromethamine.

See THAM

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.