Devimistat

Northwestern University · Phase 2 active Small molecule

Devimistat is a Small molecule drug developed by Northwestern University. It is currently in Phase 2 development. Also known as: Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Devimistat
Also known as	Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613
Sponsor	Northwestern University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations (PHASE2)
• Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04) (PHASE1, PHASE2)
• CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma (PHASE1)
• CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma (PHASE2)
• CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer (PHASE2)
• CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer (PHASE1, PHASE2)
• CPI-613 in Treating Patients With Myelodysplastic Syndromes Who Failed Previous Therapy (PHASE2)
• CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma (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:

• Devimistat CI brief — competitive landscape report
• Devimistat updates RSS · CI watch RSS
• Northwestern University portfolio CI

Frequently asked questions about Devimistat

What is Devimistat?

Devimistat is a Small molecule drug developed by Northwestern University.

Who makes Devimistat?

Devimistat is developed by Northwestern University (see full Northwestern University pipeline at /company/northwestern-university).

Is Devimistat also known as anything else?

Devimistat is also known as Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613.

What development phase is Devimistat in?

Devimistat is in Phase 2.

Related

• Manufacturer: Northwestern University — full pipeline
• Therapeutic area: All drugs in Other
• Also known as: Alpha-Lipoic Acid Analogue CPI-613, CPI 613, CPI-613