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Cingal

Anika Therapeutics, Inc. · Phase 3 active Small molecule ✓ Verified May 2026 Quality 15/100

Cingal is a Small molecule drug developed by Anika Therapeutics, Inc.. It is currently in Phase 3 development. Also known as: HA + TH.

Cingal is a treatment that combines hyaluronic acid with triamcinolone hexacetonide, used to study conditions such as knee osteoarthritis and anterior knee pain syndrome. It has been studied in clinical trials as a single injection treatment for these conditions.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameCingal
Also known asHA + TH
SponsorAnika Therapeutics, Inc.
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 3

Approved indications

No approved indications tracked.

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Cingal

What is Cingal?

Cingal is a Small molecule drug developed by Anika Therapeutics, Inc..

Who makes Cingal?

Cingal is developed by Anika Therapeutics, Inc. (see full Anika Therapeutics, Inc. pipeline at /company/anika-therapeutics-inc).

Is Cingal also known as anything else?

Cingal is also known as HA + TH.

What development phase is Cingal in?

Cingal is in Phase 3.

What are the side effects of Cingal?

Common side effects of Cingal include Headache, Arthralgia, Viral upper respiratory tract infection, Injection site pain, Joint swelling, Toothache.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing