Last reviewed 2026-04-22 · How we verify

BDP DPI 2 months

Chiesi Farmaceutici S.p.A. · Phase 3 active Small molecule

BDP DPI 2 months is a Inhaled corticosteroid Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD). Also known as: Clenil® Pulvinal®.

BDP (beclomethasone dipropionate) is an inhaled corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors in the lungs.

BDP (beclomethasone dipropionate) is an inhaled corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors in the lungs. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).

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	BDP DPI 2 months
Also known as	Clenil® Pulvinal®
Sponsor	Chiesi Farmaceutici S.p.A.
Drug class	Inhaled corticosteroid
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Respiratory / Pulmonology
Phase	Phase 3

Mechanism of action

Beclomethasone dipropionate is a topical corticosteroid delivered via dry powder inhaler (DPI) that suppresses inflammatory responses in the respiratory tract by activating glucocorticoid receptors on immune cells and epithelial cells. This reduces mucus production, airway edema, and eosinophil infiltration. The 2-month formulation likely refers to a sustained-release or extended-dosing regimen to improve treatment adherence.

Approved indications

Asthma maintenance therapy
Chronic obstructive pulmonary disease (COPD)

Common side effects

Oropharyngeal candidiasis
Dysphonia
Tremor
Headache
Throat irritation

Key clinical trials

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:

BDP DPI 2 months CI brief — competitive landscape report
BDP DPI 2 months updates RSS · CI watch RSS
Chiesi Farmaceutici S.p.A. portfolio CI

Frequently asked questions about BDP DPI 2 months

What is BDP DPI 2 months?

BDP DPI 2 months is a Inhaled corticosteroid drug developed by Chiesi Farmaceutici S.p.A., indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).

How does BDP DPI 2 months work?

BDP (beclomethasone dipropionate) is an inhaled corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors in the lungs.

What is BDP DPI 2 months used for?

BDP DPI 2 months is indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).

Who makes BDP DPI 2 months?

BDP DPI 2 months is developed by Chiesi Farmaceutici S.p.A. (see full Chiesi Farmaceutici S.p.A. pipeline at /company/chiesi-farmaceutici-s-p-a).

Is BDP DPI 2 months also known as anything else?

BDP DPI 2 months is also known as Clenil® Pulvinal®.

What drug class is BDP DPI 2 months in?

BDP DPI 2 months belongs to the Inhaled corticosteroid class. See all Inhaled corticosteroid drugs at /class/inhaled-corticosteroid.

What development phase is BDP DPI 2 months in?

BDP DPI 2 months is in Phase 3.

What are the side effects of BDP DPI 2 months?

Common side effects of BDP DPI 2 months include Oropharyngeal candidiasis, Dysphonia, Tremor, Headache, Throat irritation.

What does BDP DPI 2 months target?

BDP DPI 2 months targets Glucocorticoid receptor and is a Inhaled corticosteroid.

Drug class: All Inhaled corticosteroid drugs
Target: All drugs targeting Glucocorticoid receptor
Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
Therapeutic area: All drugs in Respiratory / Pulmonology
Indication: Drugs for Asthma maintenance therapy
Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Also known as: Clenil® Pulvinal®

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