N91115

Nivalis Therapeutics, Inc. · Phase 1 active Small molecule

N91115 is a Small molecule drug developed by Nivalis Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: Cavosonstat.

N91115 is a small molecule drug that inhibits alcohol dehydrogenase class III. It is being studied in clinical trials for conditions such as asthma, cystic fibrosis, and chronic obstructive pulmonary disease (COPD).

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 1 → approval rate +9.6pp
  Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	N91115
Also known as	Cavosonstat
Sponsor	Nivalis Therapeutics, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study (PHASE2)
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
• MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9) (PHASE1)
• Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation (PHASE2)
• MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects (PHASE1)
• Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor (PHASE2)
• PK Study of N91115 in Cystic Fibrosis Patients (PHASE1)
• A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects (PHASE1)

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:

• N91115 CI brief — competitive landscape report
• N91115 updates RSS · CI watch RSS
• Nivalis Therapeutics, Inc. portfolio CI

Frequently asked questions about N91115

What is N91115?

N91115 is a Small molecule drug developed by Nivalis Therapeutics, Inc..

Who makes N91115?

N91115 is developed by Nivalis Therapeutics, Inc. (see full Nivalis Therapeutics, Inc. pipeline at /company/nivalis-therapeutics-inc).

Is N91115 also known as anything else?

N91115 is also known as Cavosonstat.

What development phase is N91115 in?

N91115 is in Phase 1.

Related

• Manufacturer: Nivalis Therapeutics, Inc. — full pipeline
• Also known as: Cavosonstat