TheraRadar
Data updated: May 26, 2026

BAL (dimercaprol)

CNS Approved 1946-05-06

BAL is indicated for the treatment of Premenstrual Syndrome; Irregular Menstrual Cycle; Water Retention; Depression.

Source: FDA Label • PROVEPHARM SAS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
80
Years on Market

Details

Status
Prescription
First Approved
1946-05-06
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

PROVEPHARM SAS
Active Ingredient: DIMERCAPROL

BAL Approval History

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Original
New Indication
New Form
Label Update
7 FDA actions from 1946 to 2026
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Apr 2007 SUPPL
Label · Labeling
FDA Letter Label

What BAL Treats

4 indications

BAL is approved for 4 conditions since its original approval in 1946. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Premenstrual Syndrome
  • Irregular Menstrual Cycle
  • Water Retention
  • Depression
Source: FDA Label

BAL Competitive Set

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

Indication competitors

10

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

RALDESY
KAMAT
2024 1 indic.
ZURNAI (AUTOINJECTOR)
PURDUE PHARMA
2024 2 indic.
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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 BAL

3 of 9

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

AMOXAPINE
AMOXAPINE
1 shared
WATSON PHARMS TEVA
Shared indications:
Depression
DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE
1 shared
ANI PHARMS
Shared indications:
Depression
IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE
1 shared
Novartis
Shared indications:
Depression
View all 9 similar drugs Pro
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

BAL FDA Label Details

Indications & Usage

FDA Label (PDF)

BAL is indicated for the treatment of Premenstrual Syndrome; Irregular Menstrual Cycle; Water Retention; Depression.

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Data Sources

FDA Approval: NDA005939 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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