IMNOVID

Celgene · Phase 2 active Small molecule

IMNOVID is a Small molecule drug developed by Celgene. It is currently in Phase 2 development. Also known as: pomalidomide, CC-4047, BMS-986379.

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	IMNOVID
Also known as	pomalidomide, CC-4047, BMS-986379
Sponsor	Celgene
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
• Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment (PHASE1, PHASE2)
• Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (PHASE2)
• A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
• Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (PHASE2)
• A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
• A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (PHASE3)
• MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) (PHASE3)

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:

• IMNOVID CI brief — competitive landscape report
• IMNOVID updates RSS · CI watch RSS
• Celgene portfolio CI

Frequently asked questions about IMNOVID

What is IMNOVID?

IMNOVID is a Small molecule drug developed by Celgene.

Who makes IMNOVID?

IMNOVID is developed by Celgene (see full Celgene pipeline at /company/celgene).

Is IMNOVID also known as anything else?

IMNOVID is also known as pomalidomide, CC-4047, BMS-986379.

What development phase is IMNOVID in?

IMNOVID is in Phase 2.

Related

• Manufacturer: Celgene — full pipeline
• Also known as: pomalidomide, CC-4047, BMS-986379