Last reviewed 2026-05-31 · How we verify

GFF MDI (PT 003)

Pearl Therapeutics, Inc. · Phase 3 active Small molecule ✓ Verified May 2026

GFF MDI (PT 003) is a Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA) Small molecule drug developed by Pearl Therapeutics, Inc.. It is currently in Phase 3 development for Maintenance treatment of asthma, Maintenance treatment of chronic obstructive pulmonary disease (COPD).

GFF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD.

GFF MDI (PT 003) is a small molecule intervention being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being evaluated in a clinical trial, along with other interventions, to assess its safety and efficacy in patients with moderate to very severe 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	GFF MDI (PT 003)
Sponsor	Pearl Therapeutics, Inc.
Drug class	Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA)
Target	Beta-2 adrenergic receptor; Muscarinic M3 receptor
Modality	Small molecule
Therapeutic area	Respiratory / Pulmonology
Phase	Phase 3

Mechanism of action

PT 003 (GFF MDI) combines glycopyrronium, a long-acting muscarinic antagonist, with formoterol, a long-acting beta-2 agonist, in a single metered-dose inhaler formulation. This dual-action approach provides bronchodilation through two complementary mechanisms: beta-2 agonist-mediated smooth muscle relaxation and muscarinic receptor antagonism, improving airflow and reducing symptoms in obstructive airway diseases.

Approved indications

Maintenance treatment of asthma
Maintenance treatment of chronic obstructive pulmonary disease (COPD)

Common side effects

Tremor
Headache
Palpitations
Dry mouth
Nervousness

Key clinical trials

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3) (PHASE3)

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:

GFF MDI (PT 003) CI brief — competitive landscape report
GFF MDI (PT 003) updates RSS · CI watch RSS
Pearl Therapeutics, Inc. portfolio CI

Frequently asked questions about GFF MDI (PT 003)

What is GFF MDI (PT 003)?

GFF MDI (PT 003) is a Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA) drug developed by Pearl Therapeutics, Inc., indicated for Maintenance treatment of asthma, Maintenance treatment of chronic obstructive pulmonary disease (COPD).

How does GFF MDI (PT 003) work?

GFF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist delivered via metered-dose inhaler for maintenance treatment of asthma and COPD.

What is GFF MDI (PT 003) used for?

GFF MDI (PT 003) is indicated for Maintenance treatment of asthma, Maintenance treatment of chronic obstructive pulmonary disease (COPD).

Who makes GFF MDI (PT 003)?

GFF MDI (PT 003) is developed by Pearl Therapeutics, Inc. (see full Pearl Therapeutics, Inc. pipeline at /company/pearl-therapeutics-inc).

What drug class is GFF MDI (PT 003) in?

GFF MDI (PT 003) belongs to the Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA) class. See all Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA) drugs at /class/long-acting-beta-2-agonist-long-acting-muscarinic-antagonist-combination-laba-lama.

What development phase is GFF MDI (PT 003) in?

GFF MDI (PT 003) is in Phase 3.

What are the side effects of GFF MDI (PT 003)?

Common side effects of GFF MDI (PT 003) include Tremor, Headache, Palpitations, Dry mouth, Nervousness.

What does GFF MDI (PT 003) target?

GFF MDI (PT 003) targets Beta-2 adrenergic receptor; Muscarinic M3 receptor and is a Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA).

Drug class: All Long-acting beta-2 agonist / Long-acting muscarinic antagonist combination (LABA/LAMA) drugs
Target: All drugs targeting Beta-2 adrenergic receptor; Muscarinic M3 receptor
Manufacturer: Pearl Therapeutics, Inc. — full pipeline
Therapeutic area: All drugs in Respiratory / Pulmonology
Indication: Drugs for Maintenance treatment of asthma
Indication: Drugs for Maintenance treatment of chronic obstructive pulmonary disease (COPD)

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