CAPRO™ Platform
Patented polymer excipient · Release by design
MORE™ Platform
Patent-pending oral wafer · OTC + Rx
Sustained Release
SubQ · IM · IA · Biodegradable implant
Cleavable linker Cleavable linker Cleavable linker Func. block Func. block Func. block
Patented · New excipient class Pre-IND FDA ✓

CAPRO™ —
Release kinetics.
Programmed by design.

CAPRO™ is Trekka's patented biodegradable polymer excipient platform. Functional polymer blocks connected by cleavable linkers pre-program release kinetics at the molecular level — before the formulation ever reaches the patient. No organic solvents. No acidic byproducts. No modification to the API.

Patented LAI market: $19B growing to $57B by 2034 505(b)(2) for every partner program Injectable · Oral · Topical · Sublingual
CAPRO™ Polymer Architecture
Functional block A Functional block B Functional block C ✂ Cleavable linker ✂ Cleavable linker API Select the linker type → set the release duration
Release kinetics comparison
Day 0 Day 30 Day 90 Conc. 20–25% burst PLGA (legacy) CAPRO™ zero-order CAPRO™ first-order
The science

A new class of excipient — not an improvement on any existing platform.

CAPRO™ is a structurally distinct biodegradable polymer architecture. Every existing delivery platform — PLGA microspheres, in situ forming implants, liposomes, hydrogels, and PEGylation — shares fundamental limitations: harsh processing, toxic degradation products, limited release tunability, or API modification that resets the regulatory clock. CAPRO™ was designed to solve all of them in one platform.

Three things no other platform can match
1
Release kinetics programmed by design
Cleavable linkers built into the polymer backbone set the release rate before any contact with the body. Change the linker, change the duration — from days to months. No other excipient platform offers this level of pre-programmed control.
Zero-orderFirst-orderDays to months
2
Room temperature — no heat, no solvents, no degradation
Every competing platform requires heat, organic solvents, or mechanical stress — all of which damage sensitive APIs and compound at manufacturing scale. CAPRO™ is a physical mixing process at room temperature. Full API integrity, every batch.
Solvent-freeBiologic-compatibleScale-up safe
3
Clean degradation — no acidic byproducts, no inflammation
Competing polymers degrade to acids that damage the API and inflame tissue at the depot site. CAPRO™ degrades to non-toxic, endotoxin-free molecules — preserving the API and tissue environment throughout the full release window.
Non-toxic byproductsNeutral pHNo inflammation
Key structural properties
Functional polymer blocks
A diverse library of biocompatible polymer segments that can be selected and combined to tune solubility enhancement, hydrophobicity, and API encapsulation properties for specific molecule classes.
Cleavable linkers — the release programmer
The core innovation: chemically distinct linkers that undergo hydrolysis at precisely controlled rates. Selecting the linker type directly determines whether release is zero-order, first-order, or pulsatile — and whether the duration is days, weeks, or months.
Highly tunable — broadly applicable
The same platform accommodates small molecule drugs, peptides, proteins, nucleic acids, and vaccines. The polymer architecture is adapted per API — making CAPRO™ functional across virtually every formulation challenge encountered in modern drug development.
Scalable manufacturing — simple, GMP-compatible process
CAPRO™ formulation is a physical mixing process — no solvent removal, no microsphere atomization, no complex emulsion steps. GMP-compatible manufacturing processes are being developed alongside pre-clinical programs, designed for technology transfer once regulatory milestones are achieved.
Core capabilities

Four formulation challenges. One platform solves all of them.

CAPRO™ is applicable to four distinct problem categories — each addressable independently, or in combination when a molecule presents multiple challenges simultaneously.

Capability 01
Solubility & Bioavailability Enhancement
40% of marketed drugs and 90% of pipeline candidates have solubility-limited bioavailability. CAPRO™'s hydrophobic polymer matrix creates a favorable dissolution environment for BCS Class II and IV molecules — increasing absorption without ever modifying the API. The full established safety database stays intact.
CAPRO™ enhances apparent solubility through hydrophobic matrix encapsulation — without modifying the API. Existing safety data stays intact, the 505(b)(2) pathway remains available, and the molecule reaches therapeutic plasma levels it previously couldn't achieve.
BCS ClassificationClass IIClass IVCAPROAddresses both
BCS Class II & IV
40% of marketed drugs and 90% of pipeline candidates face solubility-limited bioavailability.
API UnchangedAPIUnchanged505(b)(2)
505(b)(2) preserved
CAPRO™ never modifies the API — existing safety database intact, faster path to NDA.
Dissolution ProfileCAPRO™Free API
Enhanced dissolution
Hydrophobic matrix increases apparent solubility — measurably improving absorption.
Batch ReproducibilityCAPRO™LegacyBatch 1Batch N
Predictable batch-to-batch
Linker chemistry — not polymer Mw or crystallinity — determines release. Same result every batch, at any scale.
Capability 02
Biologic Stabilization & Cold Chain Elimination
Biologics — peptides, proteins, vaccines, and nucleic acids — cannot survive the solvents, heat, or shear required by conventional delivery platforms. CAPRO™'s room-temperature, solvent-free process preserves full biologic structural integrity, making it the only viable excipient for long-acting injectable delivery of sensitive biologics.
CAPRO™'s room-temperature, solvent-free process is the only formulation approach that preserves biologic structural integrity from bench to depot — making it the only viable platform for long-acting biologic injectable delivery without organic solvent exposure.
Process TemperaturePLGAHigh heat+ solventsCAPRO™Room temp
Room-temperature process
No heat, no solvent, no shear — the three leading causes of biologic denaturation all eliminated.
Organic Solvents UsedNMPDMSO0solventsConventionalCAPRO™
Zero organic solvents
No NMP, DMSO, or any organic solvent that would degrade sensitive biologics during formulation.
pH at Depot SiteLactic acidpH 3–4Damages APINeutralpH maintainedPLGACAPRO™
Neutral pH in vivo
No acidic byproducts — API integrity and tissue health preserved throughout the depot period.
Biologic LAI CandidatesGLP-1sPeptidesVaccinesCytokines
Biologic LAI candidates
GLP-1 agonists, peptide hormones, cancer vaccines, and cytokines are all CAPRO™ LAI candidates.
Capability 03
Long-Acting Injectable & Controlled Depot Release
The LAI market is growing at 13% annually — and the biggest barrier has always been the excipient. CAPRO™ enables SubQ, IM, intra-articular, and biodegradable implant formats with zero burst release, no acidic byproducts, and release durations from days to twelve months. Duration is set by linker chemistry — not reverse-engineered from manufacturing.
CAPRO™ supports SubQ, IM, intra-articular, and biodegradable implant formats — with release duration set by linker chemistry, not manufacturing conditions. The same platform that enables daily depot release also enables 12-month sustained release, without changing the base polymer architecture.
CAPRO™ depot delivery formats
SubQ depot
1 wk – 3 months
IM depot
2 wks – 6 months
Intra-articular
Up to 3 months
Biodegradable implant
3 – 12+ months
Full LAI platform detail
Capability 04
Multi-Route Applicability — Injectable, Oral, Topical
One platform — injectable depots, oral, sublingual via MORE™, and topical. For oral delivery, CAPRO™ enhances conventional dose forms or works within MORE™ wafer layers, unlocking APIs that tablets alone cannot handle.
One platform, four delivery routes — injectable (SubQ, IM, IA, implant), oral (tablet, wafer), sublingual (MORE™ + CAPRO), and topical. No comparable legacy excipient system spans all four routes.
Injectable
SubQ · IM · IA · Implant depot
Oral
Tablets · CAPRO-enhanced capsule
Sublingual / Buccal
MORE™ + CAPRO wafer platform
Topical
Controlled transdermal release
Combination products
CAPRO™ is explicitly applicable to combination therapeutics — formulations containing more than one API — where independent release of each component can be pre-programmed using different linker types within the same polymer matrix.
Platform differentiation

Competing technologies & their weaknesses —
how CAPRO™ solves every one.

Every existing delivery technology has fundamental structural limitations. CAPRO™ was designed from first principles to address all of them simultaneously.

Competing technologyLimitationWeaknessCAPRO™ advantage
In situ forming implant systemsLiquid polymers that solidify in vivoSolvent toxicityInjecting large amounts of potentially harmful organic solvents directly into the patient's bodyCompletely solvent-free at every stage of formulation and delivery
Release controlRate depends on in vivo conditions rather than pre-set chemistryPre-programmable release tunable by selecting functional blocks and linker structure
ManufacturingComplicated chemistry — difficult to reproduce and scale to GMP standardSimple physical mixing — straightforward CMO technology transfer
Microspheres & nanoparticles of polyestersPLA, PLGA and related polymersHeat & scale-up failureHigh temperature and mechanical stress damages API — failures amplified at commercial batch sizesRoom-temperature physical mixing — API integrity preserved identically from bench to commercial scale
Acidic byproductsDegrades to lactic and glycolic acid — acidic microenvironment damages API and causes chronic inflammationNo acidic byproducts — neutral pH and biocompatible degradation throughout the full depot period
Liposomes & lipid nanoparticlesPhospholipid vesicle systemsShort durationRapid in vivo clearance — unsuitable for LAI programs requiring weeks to monthsDays to months — duration set by linker chemistry, not subject to clearance variability
Release controlVesicle leakage and instability make kinetics unpredictable batch to batchPre-programmed polymer erosion via cleavable linkers — predictable and reproducible every batch
HydrogelsCrosslinked hydrophilic networksSolubility mismatchHydrophilic matrix incompatible with BCS Class II & IV moleculesHydrophobic matrix fully solubilizes poorly soluble drugs — handles BCS Class II and IV
Short durationRapid swelling and erosion limits depot life to hours or daysSustained release — backbone erosion pre-programmed by linker selection, days to months
Burst releaseSurface drug releases immediately on contact — spike then sub-therapeutic levelsZero or first-order kinetics — full profile set by cleavable linker design before in vivo exposure
PEGylation & pro-drug approachesChemical modification of the APIRegulatory resetModifying the API creates a new chemical entity — full 505(b)(1) NDA with entirely new safety datasetsAPI structure never altered — existing safety data preserved, 505(b)(2) always available
CAPRO™ is the only platform that simultaneously addresses all of these limitations.
No competing technology eliminates burst release, acidic byproducts, solvent toxicity, and heat-driven scale-up failure — while keeping the API structurally unchanged for 505(b)(2) and enabling multi-route delivery.
Regulatory pathway for partners

505(b)(2) is available to every partner program —
approved API or new molecule into LAI.

CAPRO™ never modifies the API — which means 505(b)(2) is available for every program. Whether you're converting an approved drug into an LAI or bringing a new molecule to CAPRO™, the regulatory path is cleaner and faster than a full NDA from scratch.

1
Molecule evaluation
Your API — approved or new — evaluated for CAPRO™ platform fit, route, and release target
2
Formulation development
CAPRO™ polymer selection, GMP batch manufacturing, characterization studies
3
Pre-IND engagement
FDA pre-IND feedback received — regulatory path confirmed, Pre-clinical studies underway
4
IND filing & Phase I
505(b)(2) IND submission using established safety data from approved API
5
NDA approval
505(b)(2) NDA — faster, lower-cost path leveraging existing safety database
505(b)(2) Advantage
CAPRO™ doesn't alter the API — full established safety database is preserved and referenced. No need to repeat safety studies from scratch. Dramatically shorter, lower-cost path to NDA vs. a full 505(b)(1) submission for a novel molecule.
Pre-IND FDA Engagement
Trekka has received pre-IND feedback from the FDA — confirming the regulatory path for CAPRO™ formulations. This removes a significant early-stage uncertainty from any partnership and means clinical development can proceed with regulatory clarity in place.
GMP Manufacturing
Trekka is developing GMP-compatible manufacturing processes for CAPRO™ formulations alongside pre-clinical programs. Process documentation and manufacturing expertise are being built to support technology transfer once pre-clinical and regulatory milestones are reached.
What molecules CAPRO™ works with

Small molecules, biologics, vaccines —
one platform, broadly applicable.

CAPRO™ is adapted per molecule type — the platform's tunability means formulation parameters are optimized for each specific API class rather than applied generically.

BCS Class II & IV Small Molecules
CAPRO™'s hydrophobic matrix enhances dissolution for BCS Class II & IV molecules without modifying the API. 505(b)(2) preserved.
Pain · CNS · Oncology · Cardiovascular · Anti-infective
Peptides & Proteins
Solvent-free, room-temperature formulation preserves protein and peptide activity where every other platform fails. SubQ LAI and oral delivery both supported.
GLP-1 analogs · Insulin · Cytokines · Growth factors
Vaccines & Immunologics
Compatible with thermally sensitive antigens — no heat, no solvents. SubQ LAI depot enables single-dose, extended-duration protection.
Cancer vaccines · Infectious disease · Combination vaccines
Nucleic Acids (siRNA, mRNA, ASO)
Neutral-pH biodegradation and solvent-free processing protect nucleic acids from heat and pH exposure that conventional platforms cannot avoid.
Gene therapy · RNA therapeutics · Oligonucleotides
Poorly Stable Small Molecules
The polymer matrix stabilizes chemically labile APIs through manufacturing and the full delivery window. Works standalone or combined with MORE™ for oral delivery.
Antifungals · Proton pump inhibitors · Neurological agents
Combination Products
Two or more APIs with independently programmed release rates in the same matrix. Fixed-dose combination LAIs and multi-API wafers not achievable with any single-excipient platform.
Fixed-dose combinations · Multi-API depots · Sequential release
Have a molecule that fits?
Tell us what you're working on.
Whether you have a BCS IV molecule with poor solubility, a biologic with cold-chain limitations, a short-half-life API that needs LAI conversion, or a consumer product that should be a wafer — Trekka will evaluate the fit and show you what CAPRO™ can do. All inquiries are treated confidentially.
Response within 48 hours
All inquiries treated confidentially
No commitment required