Last reviewed 2026-05-25 · How we verify

BD MDI 80 µg

Pearl Therapeutics, Inc. · Phase 2 active Small molecule ✓ Verified May 2026

BD MDI 80 µg is a Inhaled corticosteroid/long-acting beta-2 agonist combination Small molecule drug developed by Pearl Therapeutics, Inc.. It is currently in Phase 2 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD). Also known as: PT008.

BD MDI 80 µg is a budesonide/formoterol combination inhaler that reduces airway inflammation and improves bronchodilation for respiratory disease management.

BD MDI 80 µg is a small molecule medication used to treat asthma. It is administered via a metered dose inhaler, which delivers a combination of budesonide and albuterol sulfate.

Likelihood of approval

15.3% 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).

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	BD MDI 80 µg
Also known as	PT008
Sponsor	Pearl Therapeutics, Inc.
Drug class	Inhaled corticosteroid/long-acting beta-2 agonist combination
Target	Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
Modality	Small molecule
Therapeutic area	Respiratory/Pulmonology
Phase	Phase 2

Mechanism of action

Budesonide is an inhaled corticosteroid that suppresses airway inflammation by binding glucocorticoid receptors, while formoterol is a long-acting beta-2 agonist that relaxes bronchial smooth muscle and improves airflow. Together, they provide both anti-inflammatory and bronchodilatory effects in a metered-dose inhaler formulation.

Approved indications

Asthma maintenance therapy
Chronic obstructive pulmonary disease (COPD)

Common side effects

Tremor
Headache
Palpitations
Oral candidiasis
Nervousness

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:

BD MDI 80 µg CI brief — competitive landscape report
BD MDI 80 µg updates RSS · CI watch RSS
Pearl Therapeutics, Inc. portfolio CI

Frequently asked questions about BD MDI 80 µg

What is BD MDI 80 µg?

BD MDI 80 µg is a Inhaled corticosteroid/long-acting beta-2 agonist combination drug developed by Pearl Therapeutics, Inc., indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).

How does BD MDI 80 µg work?

BD MDI 80 µg is a budesonide/formoterol combination inhaler that reduces airway inflammation and improves bronchodilation for respiratory disease management.

What is BD MDI 80 µg used for?

BD MDI 80 µg is indicated for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).

Who makes BD MDI 80 µg?

BD MDI 80 µg is developed by Pearl Therapeutics, Inc. (see full Pearl Therapeutics, Inc. pipeline at /company/pearl-therapeutics-inc).

Is BD MDI 80 µg also known as anything else?

BD MDI 80 µg is also known as PT008.

What drug class is BD MDI 80 µg in?

BD MDI 80 µg belongs to the Inhaled corticosteroid/long-acting beta-2 agonist combination class. See all Inhaled corticosteroid/long-acting beta-2 agonist combination drugs at /class/inhaled-corticosteroid-long-acting-beta-2-agonist-combination.

What development phase is BD MDI 80 µg in?

BD MDI 80 µg is in Phase 2.

What are the side effects of BD MDI 80 µg?

Common side effects of BD MDI 80 µg include Tremor, Headache, Palpitations, Oral candidiasis, Nervousness.

What does BD MDI 80 µg target?

BD MDI 80 µg targets Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) and is a Inhaled corticosteroid/long-acting beta-2 agonist combination.

Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist combination drugs
Target: All drugs targeting Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
Manufacturer: Pearl Therapeutics, Inc. — 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: PT008

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