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Verteporfin | CAS No: 129497-78-5 | GMP-certified suppliers
A medication that addresses vision‑threatening ocular neovascular disorders such as AMD, pathologic myopia, and ocular histoplasmosis, and is also applied in selected tumor destruction settings.
Therapeutic categories
Antineovascularisation AgentsDermatologicalsEENT Drugs, MiscellaneousHeterocyclic Compounds, Fused-RingOcular Vascular Disorder AgentsOphthalmologicals
Generic name
Verteporfin
Molecule type
small molecule
CAS number
129497-78-5
DrugBank ID
DB00460
Approval status
Approved drug, Investigational drug
ATC code
S01LA01
Primary indications
- For the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome
- Verteporfin can also be used to destroy tumors
Product Snapshot
- Verteporfin is supplied as an intravenous injectable powder for reconstitution
- It is used in photodynamic applications for choroidal neovascularization associated with AMD, pathologic myopia, ocular histoplasmosis, and for certain tumor-destruction uses
- It holds approvals in the US, Canada, and EU, with additional investigational status in some regions
Clinical Overview
Verteporfin (CAS 129497-78-5) is a benzoporphyrin derivative photosensitizer used in photodynamic therapy for ocular neovascular diseases. Clinically, it is indicated for predominantly classic subfoveal choroidal neovascularization associated with age‑related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis syndrome. It is also applied in certain oncologic settings where photodynamic cytotoxicity is desired.
The molecule is transported in plasma mainly via lipoproteins, which influences its distribution to neovascular tissue. Following intravenous administration, Verteporfin preferentially accumulates in abnormal choroidal neovasculature, though preclinical work shows presence in the retina as well. Upon activation by nonthermal red light at 693 nm in the presence of oxygen, the drug generates singlet oxygen and other short‑lived reactive oxygen species. These species induce endothelial injury, leading to vessel occlusion. Endothelial damage also triggers release of procoagulant and vasoactive mediators through lipo‑oxygenase and cyclo‑oxygenase pathways, promoting platelet aggregation, fibrin deposition, and vasoconstriction. Similar cytotoxic processes support its use in tumor‑directed photodynamic therapy.
Absorption, distribution, metabolism, and elimination parameters vary with circulating lipoprotein levels, which can affect tissue exposure. Verteporfin is generally cleared through hepatic pathways, though detailed metabolic routes are not fully characterized. Systemic exposure outside the illuminated field is typically limited by the short lifetime of photogenerated reactive species.
Safety considerations center on photosensitivity, which can persist for several days after dosing and requires strict light‑avoidance measures to reduce risk of phototoxic reactions. Localized inflammation or visual disturbances may occur following ocular photodynamic treatment due to vascular closure. Off‑target phototoxicity is a primary concern in oncology applications if illumination parameters are not precisely controlled.
Visudyne is the most widely recognized brand formulation. For API procurement, sourcing should ensure conformance with established pharmacopeial or internal specifications, robust control of impurities characteristic of porphyrin derivatives, and protection from light during handling and storage to maintain photochemical stability.
The molecule is transported in plasma mainly via lipoproteins, which influences its distribution to neovascular tissue. Following intravenous administration, Verteporfin preferentially accumulates in abnormal choroidal neovasculature, though preclinical work shows presence in the retina as well. Upon activation by nonthermal red light at 693 nm in the presence of oxygen, the drug generates singlet oxygen and other short‑lived reactive oxygen species. These species induce endothelial injury, leading to vessel occlusion. Endothelial damage also triggers release of procoagulant and vasoactive mediators through lipo‑oxygenase and cyclo‑oxygenase pathways, promoting platelet aggregation, fibrin deposition, and vasoconstriction. Similar cytotoxic processes support its use in tumor‑directed photodynamic therapy.
Absorption, distribution, metabolism, and elimination parameters vary with circulating lipoprotein levels, which can affect tissue exposure. Verteporfin is generally cleared through hepatic pathways, though detailed metabolic routes are not fully characterized. Systemic exposure outside the illuminated field is typically limited by the short lifetime of photogenerated reactive species.
Safety considerations center on photosensitivity, which can persist for several days after dosing and requires strict light‑avoidance measures to reduce risk of phototoxic reactions. Localized inflammation or visual disturbances may occur following ocular photodynamic treatment due to vascular closure. Off‑target phototoxicity is a primary concern in oncology applications if illumination parameters are not precisely controlled.
Visudyne is the most widely recognized brand formulation. For API procurement, sourcing should ensure conformance with established pharmacopeial or internal specifications, robust control of impurities characteristic of porphyrin derivatives, and protection from light during handling and storage to maintain photochemical stability.
Identification & chemistry
| Generic name | Verteporfin |
|---|---|
| Molecule type | Small molecule |
| CAS | 129497-78-5 |
| UNII | WU713D62N9 |
| DrugBank ID | DB00460 |
Pharmacology
| Summary | Verteporfin is a photosensitizing agent that accumulates preferentially in neovascular tissue, where it is activated by nonthermal red light to generate singlet oxygen and other reactive oxygen species. These reactive intermediates induce localized endothelial damage that promotes vessel occlusion through procoagulant and vasoactive pathways. The same photochemical cytotoxicity can be applied to selectively destroy certain tumor cells. |
|---|---|
| Mechanism of action | Verteporfin is transported in the plasma primarily by lipoproteins. Once verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo-oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. As singlet oxygen and reactive oxygen radicals are cytotoxic, Verteporfin can also be used to destroy tumor cells. |
| Pharmacodynamics | Verteporfin, otherwise known as benzoporphyrin derivative, is a medication used in conjunction with laser treatment to eliminate the abnormal blood vessels in the eye associated with conditions such as the wet form of macular degeneration. Verteporfin accumulates in these abnormal blood vessels and, when stimulated by nonthermal red light with a wavelength of 693 nm in the presence of oxygen, produces highly reactive short-lived singlet oxygen and other reactive oxygen radicals, resulting in local damage to the endothelium and blockage of the vessels. |
ADME / PK
| Half-life | Following intravenous infusion, verteporfin exhibits a bi-exponential elimination with a terminal elimination half-life of approximately 5-6 hours. Mild hepatic insufficiency increases half-life by approximately 20%. |
|---|---|
| Metabolism | Metabolized to a small extent to its diacid metabolite by liver and plasma esterases. NADPH-dependent liver enzyme systems (including the cytochrome P450 isozymes) do not appear to play a role in the metabolism of verteporfin. |
| Route of elimination | Elimination is by the fecal route, with less than 0.01% of the dose recovered in urine. |
Formulation & handling
- Reconstituted for intravenous use due to very low aqueous solubility and high lipophilicity, requiring appropriate solubilizing excipients.
- Light‑sensitive photosensitizer; protect powder and reconstituted solution from light during handling and administration.
- Lyophilized solid form supports improved stability; prepare solutions immediately before use to limit degradation.
Regulatory status
| Lifecycle | Most core patents for the API expired between 2010 and 2016 in the US and Canada, indicating that the product is well past the exclusivity period. With availability in the US, Canada, and the EU, the API is in a mature, broadly generic market phase. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Verteporfin is produced by a single originator manufacturer, with several specialized packagers supporting finished‑product supply across the US, Canada, and EU markets, where the branded product is well established. Patent protections in both the US and Canada have fully expired, indicating that the molecule is no longer under exclusivity. This creates conditions that allow for existing or potential generic competition depending on market entry dynamics. |
|---|
Safety
| Toxicity | Overdose of drug and/or light in the treated eye may result in nonperfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent. An overdose of drug will also result in the prolongation of the period during which the patient remains photosensitive to bright light. |
|---|
High Level Warnings:
- Excess drug exposure or high‑intensity light activation can cause retinal vascular nonperfusion, associated with risk of severe and potentially irreversible vision loss
- Overdose prolongs photosensitization duration, necessitating controlled light‑management conditions during handling and post‑activation processes
- Light‑activated reactions should be strictly regulated, as verteporfin’s photodynamic response can generate cytotoxic effects relevant to both ocular tissues and targeted tumor destruction
Verteporfin is a type of Macular degeneration drugs
Macular degeneration drugs belong to a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) specifically designed to treat macular degeneration, a common eye condition that causes vision loss in the central part of the retina. These drugs are essential for managing and slowing down the progression of the disease, offering improved visual outcomes for affected individuals.
Macular degeneration drugs primarily target the underlying mechanisms responsible for the condition. The most common type of drug used for this purpose is anti-vascular endothelial growth factor (anti-VEGF) agents. These drugs work by inhibiting the growth of abnormal blood vessels in the eye, which can leak fluid and cause damage to the macula.
The development of macular degeneration drugs involves rigorous research and clinical trials to ensure their safety and efficacy. These drugs are typically administered through intravitreal injections, directly into the eye, to deliver the medication precisely to the affected area.
Due to the growing prevalence of macular degeneration worldwide, pharmaceutical companies have been investing heavily in the research and development of new drugs and treatment options. The continuous advancements in technology and medical understanding have led to the introduction of novel therapies, including gene therapy and sustained-release drug delivery systems.
The availability of effective macular degeneration drugs is crucial for improving the quality of life for individuals affected by this condition. Early detection, regular eye examinations, and timely treatment with these drugs can help manage the disease, preserving visual function and preventing severe vision loss. It is essential for patients to consult with their healthcare professionals to determine the most appropriate macular degeneration drug based on their specific needs and medical history.
Verteporfin (Macular degeneration drugs), classified under Ophthalmic Agents
Ophthalmic agents belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category specifically designed for ophthalmic applications. These agents are formulated to treat various eye conditions and disorders. Ophthalmic agents encompass a wide range of medications, including eye drops, ointments, gels, and intraocular implants.
These agents are developed to address specific therapeutic needs related to the eyes, such as reducing intraocular pressure in glaucoma, treating inflammation and infection, relieving dryness and itching, and managing allergies. They may also be used to dilate the pupils during diagnostic procedures or surgeries.
Ophthalmic agents are formulated with precise concentrations of active ingredients to ensure efficacy and safety. Common classes of ophthalmic agents include beta-blockers, prostaglandin analogs, carbonic anhydrase inhibitors, corticosteroids, and antihistamines.
When administering ophthalmic agents, it is crucial to follow proper application techniques to ensure optimal drug delivery and minimize side effects. Eye drops, for example, are typically applied as a gentle instillation into the conjunctival sac, while ointments are applied along the lower eyelid.
These pharmaceutical API ophthalmic agents undergo rigorous quality control and regulatory scrutiny to meet industry standards and ensure patient safety. Manufacturers must comply with Good Manufacturing Practices (GMP) and adhere to stringent quality assurance protocols.
Overall, ophthalmic agents play a vital role in the management and treatment of various eye conditions, providing patients with targeted relief and improving ocular health. It is important to consult with a healthcare professional to determine the appropriate ophthalmic agent for individual needs and to receive proper guidance on usage and potential side effects.
Frequently asked questions about Verteporfin API
Sourcing
What matters most when sourcing GMP-grade Verteporfin?
Key factors include confirming GMP compliance and alignment with US, Canadian, and EU regulatory requirements. Because Verteporfin originates from a single manufacturer, verifying supply continuity and packager qualifications is essential. With patent expiry in the US and Canada, assessing the status of any generic entrants and ensuring equivalence of sourced material also matters.
Which documents are typically required when sourcing Verteporfin API?
Request the core API documentation set: . Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Verteporfin API?
Known or reported manufacturers for Verteporfin: . Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Verteporfin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Verteporfin manufacturers?
Audit reports may be requested for Verteporfin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Verteporfin API on Pharmaoffer?
Reported supplier count for Verteporfin: verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Verteporfin API?
Production countries reported for Verteporfin: . Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Verteporfin usually hold?
Common certifications for Verteporfin suppliers: . Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Verteporfin (CAS 129497-78-5) used for?
Verteporfin is a photosensitizer used in photodynamic therapy to induce targeted vascular closure in ocular neovascular diseases. It is indicated for predominantly classic subfoveal choroidal neovascularization associated with age‑related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis syndrome. Its light‑activated cytotoxicity also supports use in certain tumor‑directed photodynamic therapy settings.
Which therapeutic class does Verteporfin fall into?
Verteporfin belongs to the following therapeutic categories: Antineovascularisation Agents, Dermatologicals, EENT Drugs, Miscellaneous, Heterocyclic Compounds, Fused-Ring, Ocular Vascular Disorder Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Verteporfin mainly prescribed for?
The primary indications for Verteporfin: For the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome, Verteporfin can also be used to destroy tumors. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Verteporfin work?
Verteporfin is transported in the plasma primarily by lipoproteins. Once Verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated. Light activation of Verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo-oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. As singlet oxygen and reactive oxygen radicals are cytotoxic, Verteporfin can also be used to destroy tumor cells.
What should someone know about the safety or toxicity profile of Verteporfin?
Verteporfin’s primary safety concern is photosensitivity, which can persist for several days and requires strict light‑avoidance to prevent phototoxic reactions. Excess dosing or high‑intensity light exposure can cause retinal vascular nonperfusion with a risk of severe, potentially irreversible vision loss. Its light‑activated generation of reactive oxygen species produces localized cytotoxicity, so tightly controlled illumination parameters are essential to avoid off‑target tissue injury. Overdose may prolong the photosensitization period, necessitating extended light‑management precautions.
What are important formulation and handling considerations for Verteporfin as an API?
Verteporfin’s very low aqueous solubility and high lipophilicity require use of suitable solubilizing excipients and reconstitution immediately before intravenous administration. The lyophilized powder should be handled under light‑protected conditions, and the reconstituted solution must remain protected from light to prevent degradation of this photosensitizer. Prepare solutions only as needed to maintain stability.
Is Verteporfin a small molecule?
Verteporfin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Verteporfin?
Oral use is not supported because Verteporfin’s very low aqueous solubility and high lipophilicity require formulation as a light‑protected, reconstituted intravenous preparation. The lyophilized powder is stable, but once reconstituted it should be prepared immediately before use to limit degradation. Protection from light is essential for both the powder and solution.
Regulatory
Where is Verteporfin approved or in use globally?
Verteporfin is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Verteporfin right now?
Verteporfin is approved for use in the United States, Canada, and the European Union. Patent positions for this active ingredient are jurisdiction‑specific and depend on the relevant national filings, expirations, and any associated exclusivities.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Verteporfin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Verteporfin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Verteporfin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Verteporfin: 40 verified transactions across 9 suppliers and 9 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Verteporfin?
Market report availability for Verteporfin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
