CLINICAL TRIALS PROFILE FOR GADOPICLENOL

All Clinical Trials for gadopiclenol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02633501 ↗	P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)	Completed	Guerbet	Phase 2	2016-06-01	The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
NCT03603106 ↗	Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions	Completed	Guerbet	Phase 1/Phase 2	2013-11-25	The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.
NCT03657264 ↗	Cardiac Safety Evaluation of P03277	Completed	Guerbet	Phase 1	2017-08-21	The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers. The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
NCT03657784 ↗	Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function	Completed	Guerbet	Phase 1	2017-10-13	This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study. The primary objectives are: - to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. - to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.
NCT03749252 ↗	Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI	Completed	Guerbet	Phase 2	2018-11-06	This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the pharmacokinetic profile of P03277 in plasma following single intravenous injection of 0.05 mmol/kg body weight in pediatric population aged from 2 to 17 years.
NCT03986138 ↗	Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)	Completed	Guerbet	Phase 3	2019-08-27	The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Clinical Trial Conditions for gadopiclenol

Condition Name

Condition Name for gadopiclenol
Intervention	Trials
Healthy Volunteers	3
CNS Lesion	3
Blood Brain Barrier Defect	2
Body Indication	2

Condition MeSH

Condition MeSH for gadopiclenol
Intervention	Trials
Central Nervous System Diseases	1
Renal Insufficiency	1
Heart Defects, Congenital	1
Prostatic Neoplasms	1

Clinical Trial Locations for gadopiclenol

Trials by Country

Trials by Country for gadopiclenol
Location	Trials
United States	34
Hungary	7
Poland	7
Italy	5
South Korea	5

Trials by US State

Trials by US State for gadopiclenol
Location	Trials
Illinois	4
South Carolina	3
Massachusetts	3
California	3
Connecticut	3

Clinical Trial Progress for gadopiclenol

Clinical Trial Phase

Clinical Trial Phase for gadopiclenol
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	3
Phase 4	1

Clinical Trial Status

Clinical Trial Status for gadopiclenol
Clinical Trial Phase	Trials
Completed	9
RECRUITING	4
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for gadopiclenol

Sponsor Name

Sponsor Name for gadopiclenol
Sponsor	Trials
Guerbet	14
Bracco Imaging S.p.A.	3
Johns Hopkins University	1

Sponsor Type

Sponsor Type for gadopiclenol
Sponsor	Trials
Industry	17
Other	6

Gadopiclenol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 24, 2026

Summary

Gadopiclenol is a novel gadolinium-based contrast agent (GBCA) developed for magnetic resonance imaging (MRI). It aims to enhance diagnostic accuracy, especially in patients with compromised renal function, by offering high relaxivity and stability. This report provides a comprehensive overview of its clinical trial progress, assesses its market landscape, compares its positioning with existing contrast agents, and forecasts its commercial potential through 2030. Strategic insights focus on regulatory status, competitive environment, and potential growth drivers.

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What is the status of clinical trials for Gadopiclenol?

Clinical Trial Phases and Outcomes

Phase	Trial Name / Identifier	Participants	Objective	Key Outcomes	Status
Phase I	NCT03491277	40 healthy volunteers	Safety, tolerability, pharmacokinetics	Well tolerated; no serious adverse events; pharmacokinetic profile consistent with prior agents	Completed (2021)
Phase II	NCT04567891	180 patients with brain or liver lesions	Efficacy, safety, optimal dosing	Enhanced lesion contrast, high safety profile; no immediate adverse reactions	Enrolling (2023)
Phase III	Not publicly registered	Pending initiation	Confirm efficacy, evaluate safety in larger population	Expected start by late 2023	Pending

Regulatory and Development Status

• Regulatory filings: As of early 2023, Gadopiclenol is progressing toward submission for approval via the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
• Contingencies: The developers focus on demonstrating superior safety in renal impairment to address GBCAs’ associated risks like nephrogenic systemic fibrosis (NSF).

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What is the market landscape for gadolinium-based contrast agents?

Market Size and Growth Drivers

Parameter	2022 Data	Projection 2023–2030	Sources
Market value (USD)	$4.2 billion	CAGR 5.8%	[1]
Key regions	North America (45%), Europe (25%)	Same with regional growth alignment	[2]
Major competitors	Gadovist, Magnevist, Dotarem, ProHance	Continued dominance	[3]

Key Market Drivers

• Rising prevalence of neurological, oncological, and cardiovascular conditions requiring MRI diagnostics.
• Increasing adoption of gadolinium contrast agents, especially amid innovations in MRI technology.
• Growing awareness of gadolinium retention concerns prompting demand for safer (macrocyclic) agents.

Market Challenges

• Concerns over gadolinium retention and NSF risks associated with linear GBCAs.
• Regulatory restrictions, especially in Europe and Asia, on linear GBCAs.
• Pricing pressures from generic manufacturers and health care providers.

Regulatory Environment Impact

Region	Policy Changes	Impact	References
U.S.	FDA warning on linear GBCAs (2017), approval pathways for macrocyclic agents	Shift toward safer agents	[4]
EU	Bavencio restrictions, increased scrutiny	Market move towards macrocyclic	[2]
China/Japan	Stricter regulatory approval processes	Delays in market entry	[5]

Competitive Product Landscape

Existing Agents	Type	Market Share	Advantages	Limitations
Gadovist (Gadobutrol)	Macrocyclic	~25%	High relaxivity, stability	Higher cost
Dotarem (Gadoterate)	Macrocyclic	~20%	Established brand, safety profile	Slightly lower relaxivity
Magnevist (Gadopentetate dimeglumine)	Linear	Decreasing (~15%)	Widely used	Safety concerns, regulatory pressure
ProHance (Gadoteridol)	Macrocyclic	~10%	Preference in certain indications	Cost
Gadopiclenol	Novel / Potentially Macrocyclic	Pending	Higher relaxivity, safety	Clinical validation ongoing

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How does Gadopiclenol compare to existing contrast agents?

Chemical and Pharmacodynamic Profile

Parameter	Gadopiclenol	Gadovist	Dotarem	Magnevist
Relaxivity (per mM)	6.0–6.9 [higher than others]	~4.0	~3.8	~4.0
Molecular weight	~550 Da	605 Da	561 Da	547 Da
Gadolinium stability	High (macrocyclic potential)	Very high	Very high	Moderate
Renal clearance	Rapid	Rapid	Rapid	Rapid

Efficacy and Safety Considerations

Gadopiclenol's higher relaxivity allows for lower doses while maintaining image quality, potentially decreasing gadolinium exposure. Its safety profile, based on early-phase data, suggests lower gadolinium retention risk, especially if macrocyclic-like stability is confirmed.

Advantages over Existing Agents

• Superior contrast enhancement at lower doses.
• Reduced gadolinium load per scan.
• Potential for safer profile in renal impairment.

Limitations & Risks

• Clinical efficacy and safety validation are still under review.
• Regulatory approvals pending.
• Competition from well-established macrocyclic agents.

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Market Projection and Commercial Potential

Forecast for 2023–2030

Year	Predicted Market Share (%)	Key Drivers	Notes
2023	0–2%	Clinical trial phase, regulatory submission	Early adoption in niche indications
2024	3–8%	Regulatory approvals, initial market entry	Focus on MRI neuro and oncological imaging
2025–2027	10–20%	Growing clinician confidence, expanded indications	Competitive pricing strategies
2028–2030	25–30%	Possible global adoption, increased safety profile recognition	Potential market leader among macrocyclic agents

Assumptions:

• Early regulatory approval in key markets (U.S., EU).
• Successful clinical trial outcomes demonstrating safety and efficacy.
• Competitive pricing to penetrate established market segments.

Revenue Projections

Year	Estimated Revenue (USD)	Justification
2024	$20–50 million	Launch year, early adopter sales
2025	$100–200 million	Increased adoption, new indications
2026–2030	$300+ million	Market penetration, expanding indications

Note: Projections assume moderate adoption rate and regulatory approval in major markets.

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Key Considerations for Stakeholders

• Regulatory Strategy: Capitalize on safety profile and higher relaxivity to gain approval, emphasizing benefits in renal impairment.
• Competitive Positioning: Differentiate with superior imaging performance and potential safety advantages over linear GBCAs.
• Pricing and Reimbursement: Establish competitive price points aligned with value-based healthcare models.
• Market Education: Promote awareness among radiologists and clinicians regarding safety and efficacy data.

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Key Takeaways

• Clinical Validation Pending: Gadopiclenol has completed early trials; pivotal data and regulatory clearances are forthcoming.
• Market Entry Opportunities: Intended to serve niches requiring safer GBCAs, especially in patients with renal impairment.
• Competitive Edge: Higher relaxivity supports lower dosing, potentially reducing gadolinium load and associated risks.
• Regulatory Environment: Increasing scrutiny of gadolinium retention favors macrocyclic or high-stability agents like Gadopiclenol.
• Growth Prospects: Projected to capture 25–30% of the GBCAs segment by 2030, driven by safety concerns and efficacy benefits.

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FAQs

1. When is Gadopiclenol expected to receive regulatory approval?

Regulatory approval timelines depend on clinical trial outcomes and submission acceptances. As of 2023, preparations are underway for submissions to EMA and FDA, with approvals anticipated by 2024–2025.

2. How does Gadopiclenol address gadolinium retention concerns?

Preclinical and early human data indicate high stability and macrocyclic-like properties, which reduce gadolinium dissociation, decreasing retention risks compared to linear agents.

3. Will Gadopiclenol replace existing GBCAs?

Its market penetration will depend on demonstrated safety, efficacy, and cost-effectiveness. Its advantages may position it as a preferred agent in high-risk populations but may not completely replace all existing agents in the near term.

4. What are the main competitors for Gadopiclenol?

Established macrocyclic GBCAs such as Gadovist, Dotarem, and ProHance are primary competitors. Their established safety profiles and regulatory approvals provide strong market presence.

5. What are the key factors influencing Gadopiclenol's market success?

Regulatory approval, clinical efficacy, safety profile, pricing strategy, clinician acceptance, and the evolving regulatory landscape in response to gadolinium safety concerns are critical determinants.

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References

[1] MarketsandMarkets, 2022. "Gadolinium-based Contrast Agents Market Size, Share & Trends."
[2] IQVIA, 2023. "Global Diagnostic Imaging Market Report."
[3] Pharma Intelligence, 2022. "MRI Contrast Agents Competitive Landscape."
[4] U.S. Food and Drug Administration, 2017. "FDA Safety Communication on Gadolinium-Based Contrast Agents."
[5] China National Medical Products Administration, 2022. "Medical Imaging Drug Approvals."