Hearing-Loss Therapy Database

Therapy	Approach	Progress	Population
PEDMARK by Fennec PharmaceuticalsFennec Pharmaceuticals Compare	Small Molecule	Stage: MarketedStatus: Marketed	Children · ≥1 month (pediatric indication)Localized, non-metastatic tumors receiving cisplatin
SENS-401 (Arazasetron) by SensorionSensorion Compare	Small Molecule	Stage: Phase 2Status: Active	Adults · ≥18 yearsSSNHL, cisplatin, or cochlear-implant cohorts
AC102 by AudioCure PharmaAudioCure Pharma Compare	Small Molecule	Stage: Phase 2Status: Active	Adults · 18–85 yearsRecent severe unilateral ISSNHL
SPI-1005 by Sound PharmaceuticalsSound Pharmaceuticals Compare	Small Molecule	Stage: Phase 3Status: Active	Adults · 18–75 yearsActive Ménière’s disease
ACOU085 by Acousia TherapeuticsAcousia Therapeutics GmbH Compare	Small Molecule	Stage: Phase 2Status: Active	Adults · 18–45 yearsTesticular cancer receiving high-dose cisplatin
CIL001 (Paliroden) by CilcareCilcare SAS Compare	Small Molecule	Stage: Phase 1/2Status: Active	Adults · 45–75 yearsType 2 diabetes with speech-in-noise difficulty
OTO-313 by OtonomyOtonomy Compare	Small Molecule	Stage: Phase 2Status: Discontinued	Adults · 18–75 yearsPersistent unilateral cochlear tinnitus
AM-101 by Auris Medical and AltamiraAltamira Therapeutics Compare	Small Molecule	Stage: Phase 3Status: Discontinued	Adults · 18–75 yearsAcute post-injury tinnitus
NHPN-1010Otologic Pharmaceutics Compare	Small Molecule	Stage: Phase 1Status: Completed	Adults · 18–55 yearsHazardous noise or blast exposure
PIPE-505 by Pipeline TherapeuticsContineum Therapeutics Compare	Small Molecule	Stage: Phase 1/2Status: Completed	Adults · 18–75 yearsBilateral SNHL with speech-in-noise deficits
Isosorbide Oral Solution by Lunan Better PharmaceuticalLunan Better Pharmaceutical Co., Ltd. Compare	Small Molecule	Stage: Phase 2/3Status: Active	Adults · 18–65 yearsRecurrent unilateral Ménière’s disease
Neramexane by MerzMerz Pharmaceuticals GmbH Compare	Small Molecule	Stage: Phase 3Status: Completed	Adults · 18–75 yearsPersistent subjective tinnitus
OHSU/Oricula ORC-13661 amikacin otoprotection studyInvestigator-led study Compare	Small Molecule	Stage: Phase 2Status: Active	Adults · >18 to <80 yearsNTM infection receiving intravenous amikacin
Strekin STR001 for Sudden Sensorineural Hearing LossStrekin AG Compare	Small Molecule	Stage: Phase 3Status: Completed	Adults · ≥18 yearsAcute idiopathic or noise-trauma SSNHL

PEDMARK by Fennec Pharmaceuticals

Fennec Pharmaceuticals · Small Molecule · Marketed

MarketedTherapeuticStronger sources

Population

Children · ≥1 month (pediatric indication)

Localized, non-metastatic tumors receiving cisplatin

Evidence

regulatory

Confidence

98%

Indications

Cisplatin-Induced Hearing LossHearing Loss

Details

SENS-401 (Arazasetron) by Sensorion

Sensorion · Small Molecule · Phase 2

ActiveTherapeuticStronger sources

Population

Adults · ≥18 years

SSNHL, cisplatin, or cochlear-implant cohorts

Evidence

company

Confidence

94%

Indications

Hearing LossSensorineural Hearing LossSudden Sensorineural Hearing LossCisplatin-Induced Hearing Loss

Details

AC102 by AudioCure Pharma

AudioCure Pharma · Small Molecule · Phase 2

ActiveTherapeuticStronger sources

Population

Adults · 18–85 years

Recent severe unilateral ISSNHL

Evidence

trial

Confidence

91%

Indications

Hearing LossSensorineural Hearing LossSudden Sensorineural Hearing LossTinnitus

Details

SPI-1005 by Sound Pharmaceuticals

Sound Pharmaceuticals · Small Molecule · Phase 3

ActiveTherapeuticStronger sources

Population

Adults · 18–75 years

Active Ménière’s disease

Evidence

trial

Confidence

90%

Indications

Hearing LossSensorineural Hearing LossNoise-Induced Hearing LossTinnitus

Details

ACOU085 by Acousia Therapeutics

Acousia Therapeutics GmbH · Small Molecule · Phase 2

ActiveTherapeuticStronger sources

Population

Adults · 18–45 years

Testicular cancer receiving high-dose cisplatin

Evidence

company

Confidence

93%

Indications

Hearing LossSensorineural Hearing LossAge-Related Hearing LossCisplatin-Induced Hearing Loss

Details

CIL001 (Paliroden) by Cilcare

Cilcare SAS · Small Molecule · Phase 1/2

ActiveTherapeuticStronger sources

Population

Adults · 45–75 years

Type 2 diabetes with speech-in-noise difficulty

Evidence

trial

Confidence

92%

Indications

Hearing LossSensorineural Hearing LossHidden Hearing LossCochlear Synaptopathy

Details

OTO-313 by Otonomy

Otonomy · Small Molecule · Phase 2

DiscontinuedTherapeutic

Population

Adults · 18–75 years

Persistent unilateral cochlear tinnitus

Evidence

company

Confidence

96%

Indications

Tinnitus

Details

AM-101 by Auris Medical and Altamira

Altamira Therapeutics · Small Molecule · Phase 3

DiscontinuedTherapeutic

Population

Adults · 18–75 years

Acute post-injury tinnitus

Evidence

trial

Confidence

93%

Indications

Tinnitus

Details

NHPN-1010

Otologic Pharmaceutics · Small Molecule · Phase 1

CompletedTherapeutic

Population

Adults · 18–55 years

Hazardous noise or blast exposure

Evidence

company

Confidence

89%

Indications

Hearing LossSensorineural Hearing LossNoise-Induced Hearing LossTinnitus

Details

PIPE-505 by Pipeline Therapeutics

Contineum Therapeutics · Small Molecule · Phase 1/2

CompletedTherapeutic

Population

Adults · 18–75 years

Bilateral SNHL with speech-in-noise deficits

Evidence

trial

Confidence

86%

Indications

Hearing LossSensorineural Hearing LossHidden Hearing LossCochlear Synaptopathy

Details

Isosorbide Oral Solution by Lunan Better Pharmaceutical

Lunan Better Pharmaceutical Co., Ltd. · Small Molecule · Phase 2/3

ActiveTherapeutic

Population

Adults · 18–65 years

Recurrent unilateral Ménière’s disease

Evidence

trial

Confidence

88%

Indications

Hearing LossTinnitus

Details

Neramexane by Merz

Merz Pharmaceuticals GmbH · Small Molecule · Phase 3

CompletedTherapeutic

Population

Adults · 18–75 years

Persistent subjective tinnitus

Evidence

publication

Confidence

86%

Indications

Tinnitus

Details

OHSU/Oricula ORC-13661 amikacin otoprotection study

Investigator-led study · Small Molecule · Phase 2

ActiveTherapeutic

Population

Adults · >18 to <80 years

NTM infection receiving intravenous amikacin

Evidence

registry

Confidence

83%

Indications

Hearing LossOtotoxicityAminoglycoside-Induced Hearing Loss

Details

Strekin STR001 for Sudden Sensorineural Hearing Loss

Strekin AG · Small Molecule · Phase 3

CompletedTherapeutic

Population

Adults · ≥18 years

Acute idiopathic or noise-trauma SSNHL

Evidence

registry

Confidence

82%

Indications

Hearing LossSudden Sensorineural Hearing LossSensorineural Hearing Loss

Details

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