TheraRadar
Data updated: May 26, 2026

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (betamethasone acetate)

Respiratory Approved 2009-07-31

Betamethasone acetate and betamethasone sodium phosphate is an injectable suspension indicated for use when oral therapy is not feasible for various inflammatory, allergic, and autoimmune conditions. It is utilized across multiple specialties to manage severe or incapacitating disorders, including dermatologic, endocrine, gastrointestinal, hematologic, ophthalmic, and renal diseases. The drug also serves a therapeutic role in the palliative management of certain neoplastic diseases (leukemias and lymphomas) and the treatment of acute exacerbations of multiple sclerosis or cerebral edema.

Source: FDA Label • Hikma

How BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE Works

Betamethasone is a synthetic glucocorticoid that exerts potent anti-inflammatory and immunosuppressive effects. It diffuses across cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This receptor-ligand complex translocates to the nucleus, where it binds to glucocorticoid response elements (GREs) to modulate gene transcription. This results in the induction of anti-inflammatory proteins (such as lipocortins, which inhibit phospholipase A2) and the repression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Additionally, it reduces capillary permeability and suppresses the humoral and cell-mediated immune responses. The combination of the sodium phosphate salt (rapidly soluble) and the acetate salt (slowly soluble) provides both immediate and sustained corticosteroid activity.

Source: FDA Label
2
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-07-31
Routes
INJECTION
Dosage Forms
INJECTABLE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2009 to 2025
Sep 2025 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling
Jan 2023 ORIGINAL
Update

What BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE Treats

9 indications

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE is approved for 9 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Atopic Dermatitis
  • Contact Dermatitis
  • Drug Hypersensitivity
  • Allergic Rhinitis
  • Serum Sickness
  • Transfusion Reaction
  • Exfoliative Erythroderma
Source: FDA Label

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE Competitive Set

Pro

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

Unlock 8 more competitors across all three rings.
Upgrade to Pro

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

What's emerging in BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

3 of 20

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

CELESTONE SOLUSPAN
BETAMETHASONE ACETATE
9 shared
Merck
Shared indications:
KENALOG-40
TRIAMCINOLONE ACETONIDE
9 shared
APOTHECON
Shared indications:
DEPO-MEDROL
METHYLPREDNISOLONE ACETATE
8 shared
Pfizer
Shared indications:
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
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.

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE FDA Label Details

Indications & Usage

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Allergic Rhinitis; Serum Sickness; Transfusion Reaction; Exfoliative Erythroderma; Mycosis Fungoides.

Explore on TheraRadar

Ulcerative Colitis Drug Landscape 2026

Approved therapies, pipeline drugs, and clinical trial intelligence

See insight

Data Sources

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