TheraRadar
Data updated: May 26, 2026

Bat (botulism antitoxin heptavalent (a, b, c, d, e, f, g) - (equine))

Approved 2013-03-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-03-21
Patent Cliff
2020

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Patent cliff and revenue data

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Routes
Intravenous
Dosage Forms
Solution

Companies

Emergent BioSolutions
Active Ingredient: Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)

Bat Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2013 to 2013
Mar 2013 ORIGINAL
Update · CBER biologic (Purple Book)

What Bat Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT05639647 C3601008 2022-501575-12-00 Ph 2 recruiting Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
NCT06075706 BALDER MC-MSC.2/aGvHD 2023-503952-28-00 Ph 2 active not recruiting Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
NCT05905055 Integral-2 OP0595-6 Ph 3 completed P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
NCT04629833 IDUNN MC-MSC.1/aGvHD Ph 3 recruiting Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
NCT02577926 Ruxo-BEAT 12-181 Ph 2 active not recruiting The Ruxo-BEAT Trial in Patients With High-risk Polycythemia Vera or High-risk Essential Thrombocythemia
NCT05685615 BV100-006 Ph 2 completed PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
NCT03580044 results posted C3601009 2017-004544-38, ASSEMBLE Ph 3 terminated Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
NCT04366908 COVIDIOL COVIDIOL Ph 2 completed Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
NCT04954014 BEVACOR BEVACOR Ph 2 terminated Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
NCT02666287 201958 Ph 1 completed GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)
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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.

Bat FDA Label Details

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Data Sources

FDA Approval: BLA125462 → Trials: ClinicalTrials.gov →

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