Last reviewed 2026-04-22 · How we verify

Diclofenac HPBCD

IBSA Institut Biochimique SA · Phase 3 active Small molecule

Diclofenac HPBCD is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by IBSA Institut Biochimique SA. It is currently in Phase 3 development for Acute pain management, Postoperative pain, Musculoskeletal pain and inflammation.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Acute pain management, Postoperative pain, Musculoskeletal pain and inflammation.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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 name	Diclofenac HPBCD
Sponsor	IBSA Institut Biochimique SA
Drug class	Nonsteroidal anti-inflammatory drug (NSAID)
Target	COX-1, COX-2
Modality	Small molecule
Therapeutic area	Pain management, Rheumatology, Inflammation
Phase	Phase 3

Mechanism of action

Diclofenac blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. The HPBCD (hydroxypropyl-β-cyclodextrin) formulation is a solubilizing excipient designed to improve the drug's bioavailability and dissolution properties, potentially enabling faster onset of action or alternative routes of administration compared to conventional diclofenac formulations.

Approved indications

Acute pain management
Postoperative pain
Musculoskeletal pain and inflammation

Common side effects

Gastrointestinal upset (nausea, dyspepsia)
Abdominal pain
Headache
Dizziness
Increased cardiovascular risk
Renal impairment

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.

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:

Diclofenac HPBCD CI brief — competitive landscape report
Diclofenac HPBCD updates RSS · CI watch RSS
IBSA Institut Biochimique SA portfolio CI

Frequently asked questions about Diclofenac HPBCD

What is Diclofenac HPBCD?

Diclofenac HPBCD is a Nonsteroidal anti-inflammatory drug (NSAID) drug developed by IBSA Institut Biochimique SA, indicated for Acute pain management, Postoperative pain, Musculoskeletal pain and inflammation.

How does Diclofenac HPBCD work?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.

What is Diclofenac HPBCD used for?

Diclofenac HPBCD is indicated for Acute pain management, Postoperative pain, Musculoskeletal pain and inflammation.

Who makes Diclofenac HPBCD?

Diclofenac HPBCD is developed by IBSA Institut Biochimique SA (see full IBSA Institut Biochimique SA pipeline at /company/ibsa-institut-biochimique-sa).

What drug class is Diclofenac HPBCD in?

Diclofenac HPBCD belongs to the Nonsteroidal anti-inflammatory drug (NSAID) class. See all Nonsteroidal anti-inflammatory drug (NSAID) drugs at /class/nonsteroidal-anti-inflammatory-drug-nsaid.

What development phase is Diclofenac HPBCD in?

Diclofenac HPBCD is in Phase 3.

What are the side effects of Diclofenac HPBCD?

Common side effects of Diclofenac HPBCD include Gastrointestinal upset (nausea, dyspepsia), Abdominal pain, Headache, Dizziness, Increased cardiovascular risk, Renal impairment.

What does Diclofenac HPBCD target?

Diclofenac HPBCD targets COX-1, COX-2 and is a Nonsteroidal anti-inflammatory drug (NSAID).

Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
Target: All drugs targeting COX-1, COX-2
Manufacturer: IBSA Institut Biochimique SA — full pipeline
Therapeutic area: All drugs in Pain management, Rheumatology, Inflammation
Indication: Drugs for Acute pain management
Indication: Drugs for Postoperative pain
Indication: Drugs for Musculoskeletal pain and inflammation

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