TheraRadar
Data updated: May 26, 2026

SEEBRI NEOHALER (glycopyrrolate)

Trial Activity: Mature 2 active trials
Respiratory Approved 2015-10-29
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Chiesi Farmaceutici S.p.A. conducting 8 trials (31%)
37 indications explored (Broad Platform)
→ healthy (3 trials)
→ pulmonary disease, chronic obstructive (3 trials)
→ neuromuscular blockade (2 trials)
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-10-29
Patent Cliff
2028

Pro Metrics

Patent cliff and revenue data

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Routes
INHALATION
Dosage Forms
POWDER

Companies

Novartis
Active Ingredient: GLYCOPYRROLATE

SEEBRI NEOHALER Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2015 to 2021
Jul 2021 SUPPL
Label · Labeling
FDA Letter Label
Jan 2017 SUPPL
Label · Labeling
FDA Letter Label
May 2016 SUPPL
Mfg · Manufacturing (CMC)

What SEEBRI NEOHALER Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
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Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT05887375 2096001 MISP Database number 101357 Ph 4 completed Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
NCT05116930 21-009530 Ph 2 recruiting Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
NCT03111121 results posted 1610312153 Ph 4 completed Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
NCT06045364 2023-115 Ph 1, Ph 2 completed Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
NCT03939923 results posted 1806161309 Ph 4 completed Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
NCT03513406 STUDY00141829 Ph 3 completed Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
NCT03322657 results posted 17-764 Ph 4 completed Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
NCT01176851 Gly1 CCD-0915-PR-0031 Ph 1 completed Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
NCT01476813 CCD-1106-PR-0066 Ph 2 completed Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
NCT01176903 GLY2 CCD-0916-PR-0032 2010-018668-18 Ph 1, Ph 2 completed Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
NCT01398111 TRIPLE 1 CCD-1101-PR-0056 2011-001552-11 Ph 1 completed Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
NCT02574611 KOR-15-026 Ph 1 withdrawn Use of High Resolution Colonic Manometry in Studying Motility
NCT03138967 results posted 2015-1007 Ph 4 completed Investigation of Sugammadex in Outpatient Urological Procedures
NCT02872935 results posted 201301793 Ph 4 terminated Minimizing Nausea and Vomiting During Spinals for CS
NCT03513757 results posted CHW 959242-5 Ph 4 completed Dexmedetomidine and Propofol for Pediatric MRI Sedation
NCT02860507 results posted TGH015 Ph 4 completed Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
NCT02327923 IERB/284/014 Ph 4 completed Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
NCT02375217 ANES.MA.14 Ph 4 completed "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
NCT02613494 GOTHIC1 2015-GOTHIC1 Ph 1, Ph 2 completed Clozapine-induced Hypersalivation - Feasibility Trial
NCT01479764 results posted P07981 MK-8616-064 Ph 3 completed Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
NCT01588717 AIDES-G AIDES-G Ph 1 terminated Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)
NCT01199237 results posted H10722-35629-01 Ph 4 completed Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

SEEBRI NEOHALER FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 73 international docs across 32 countries

SEEBRI NEOHALER Patents & Exclusivity

Latest Patent: Oct 2028

Patents (2 active)

US8182838 Expires Oct 20, 2028
US8479730 Expires Oct 11, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for SEEBRI NEOHALER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 2 active patents

Trial Analysis

  • • 26 total trials
  • • Stage: Mature

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA207923 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment