Last reviewed 2026-04-23 · How we verify

Budesonide 200 microgram

AstraZeneca · Phase 2 active Small molecule

Budesonide 200 microgram is a Corticosteroid Small molecule drug developed by AstraZeneca. It is currently in Phase 2 development for Maintenance treatment of asthma, Ultrasonographically active inflammatory lesions of Crohn's disease. Also known as: Pulmicort.

Budesonide is a corticosteroid that works by inhibiting the release of pro-inflammatory mediators from mast cells and other cells.

Budesonide is a corticosteroid that works by inhibiting the release of pro-inflammatory mediators from mast cells and other cells. Used for Maintenance treatment of asthma, Ultrasonographically active inflammatory lesions of Crohn's disease.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Budesonide 200 microgram
Also known as	Pulmicort
Sponsor	AstraZeneca
Drug class	Corticosteroid
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Budesonide exerts its effects by binding to the glucocorticoid receptor, which then translocates to the nucleus and regulates the expression of various genes involved in inflammation. This leads to a decrease in the production of pro-inflammatory cytokines and other mediators, resulting in anti-inflammatory effects.

Approved indications

Maintenance treatment of asthma
Ultrasonographically active inflammatory lesions of Crohn's disease

Common side effects

Headache
Nausea
Dyspepsia
Cough
Thrush
Hypersensitivity reactions
Bone fractures
Osteoporosis
Growth suppression
Adrenal insufficiency

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Budesonide 200 microgram CI brief — competitive landscape report
Budesonide 200 microgram updates RSS · CI watch RSS
AstraZeneca portfolio CI

Frequently asked questions about Budesonide 200 microgram

What is Budesonide 200 microgram?

Budesonide 200 microgram is a Corticosteroid drug developed by AstraZeneca, indicated for Maintenance treatment of asthma, Ultrasonographically active inflammatory lesions of Crohn's disease.

How does Budesonide 200 microgram work?

Budesonide is a corticosteroid that works by inhibiting the release of pro-inflammatory mediators from mast cells and other cells.

What is Budesonide 200 microgram used for?

Budesonide 200 microgram is indicated for Maintenance treatment of asthma, Ultrasonographically active inflammatory lesions of Crohn's disease.

Who makes Budesonide 200 microgram?

Budesonide 200 microgram is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is Budesonide 200 microgram also known as anything else?

Budesonide 200 microgram is also known as Pulmicort.

What drug class is Budesonide 200 microgram in?

Budesonide 200 microgram belongs to the Corticosteroid class. See all Corticosteroid drugs at /class/corticosteroid.

What development phase is Budesonide 200 microgram in?

Budesonide 200 microgram is in Phase 2.

What are the side effects of Budesonide 200 microgram?

Common side effects of Budesonide 200 microgram include Headache, Nausea, Dyspepsia, Cough, Thrush, Hypersensitivity reactions.

What does Budesonide 200 microgram target?

Budesonide 200 microgram targets Glucocorticoid receptor and is a Corticosteroid.

Drug class: All Corticosteroid drugs
Target: All drugs targeting Glucocorticoid receptor
Manufacturer: AstraZeneca — full pipeline
Therapeutic area: All drugs in Respiratory
Indication: Drugs for Maintenance treatment of asthma
Indication: Drugs for Ultrasonographically active inflammatory lesions of Crohn's disease
Also known as: Pulmicort

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing