Last reviewed 2026-06-03 · How we verify

Placebo -AP-CD/LD

Intec Pharma Ltd. · Phase 3 active Small molecule ✓ Verified Jun 2026

Placebo -AP-CD/LD is a Small molecule drug developed by Intec Pharma Ltd.. It is currently in Phase 3 development.

AP-CD/LD is a placebo formulation designed to serve as a control comparator in clinical trials, containing no active pharmaceutical ingredient.

Placebo -AP-CD/LD is a small molecule used as a control in a clinical trial for Parkinson's Disease. It was used in a Phase 3 study to compare the efficacy of the gastric-retentive AP-CD/LD formulation with an active control, Sinemet.

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 name	Placebo -AP-CD/LD
Sponsor	Intec Pharma Ltd.
Modality	Small molecule
Phase	Phase 3

Mechanism of action

As a placebo, this formulation is used in Phase 3 clinical trials to establish baseline efficacy and safety profiles through comparison with active drug arms. Intec Pharma's AP-CD/LD designation suggests this may be a placebo variant of a proprietary delivery system, but without active drug content, it produces no direct pharmacological effect.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (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:

Placebo -AP-CD/LD CI brief — competitive landscape report
Placebo -AP-CD/LD updates RSS · CI watch RSS
Intec Pharma Ltd. portfolio CI

Frequently asked questions about Placebo -AP-CD/LD

What is Placebo -AP-CD/LD?

Placebo -AP-CD/LD is a Small molecule drug developed by Intec Pharma Ltd..

How does Placebo -AP-CD/LD work?

AP-CD/LD is a placebo formulation designed to serve as a control comparator in clinical trials, containing no active pharmaceutical ingredient.

Who makes Placebo -AP-CD/LD?

Placebo -AP-CD/LD is developed by Intec Pharma Ltd. (see full Intec Pharma Ltd. pipeline at /company/intec-pharma-ltd).

What development phase is Placebo -AP-CD/LD in?

Placebo -AP-CD/LD is in Phase 3.

Manufacturer: Intec Pharma Ltd. — full pipeline

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