Rani Therapeutics

What Rani Therapeutics does

Rani Therapeutics Holdings, Inc. (NASDAQ: RANI) is a clinical-stage biotherapeutics company developing the RaniPill® platform, a swallowable, robotic, enteric-coated capsule designed to deliver biologic drugs orally through the intestinal wall with bioavailability comparable to subcutaneous injection (102% relative to SC in human testing). The capsule's pH-responsive coating dissolves in the small intestine, where a self-inflating balloon presses dissolvable microneedles (capacity 200μL) into the highly vascularized intestinal wall for systemic absorption. The platform is payload-agnostic across peptides, proteins, monoclonal antibodies, and nucleotides, with 400+ granted/pending patents and 250+ granted patents worldwide protecting it. Safety has been demonstrated across 233 administrations in 146 humans with no serious adverse events.

The company monetizes via enterprise B2B licensing and co-development partnerships with large pharmaceutical and biopharmaceutical companies rather than direct drug sales. Its two flagship partnerships are a worldwide license with Chugai Pharmaceutical valued at up to $1.085 billion covering RT-117 and 11 predefined targets (rare disease), and a 50/50 worldwide co-development with ProGen Co., Ltd. for RT-114 (oral GLP-1/GLP-2 for obesity). Celltrion supplies ustekinumab and adalimumab biosimilars used in RT-111 and RT-105. Rani is publicly traded (NASDAQ: RANI), headquartered in San Jose, CA with a secondary office in Fremont, CA, and was spun out of Mir Imran's InCube Labs.

Name

Rani Therapeutics

Legal name

Rani Therapeutics Holdings, Inc.

Website

https://ranitherapeutics.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

101–250 employees

Short description

Rani Therapeutics is a clinical-stage biotherapeutics company developing the RaniPill®, a swallowable robotic capsule that delivers biologic drugs orally with subcutaneous-comparable bioavailability. It licenses the platform and co-develops oral biologic candidates with large pharma partners including Chugai, ProGen, and Celltrion.

Ownership category

akta.pro rank

Product category

Oral Biologics Drug Delivery Systems

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

Keywords

• Oral biologic delivery
• Robotic capsule platform
• Drug delivery systems
• Biotherapeutics development
• Oral biologics platform

Headquarters

HQ city

San Jose

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Others

Revenue model

1. Collaboration & License Revenue (Chugai): Worldwide collaboration and license agreement with Chugai Pharmaceutical valued at up to $1.085 billion, including upfront payment, success milestones, and royalties for use of the RaniPill® platform to develop an oral therapy for a rare disease (RT-117, 11 predefined targets). Q1 2026 contract revenue of $1.7M (vs. $0.2M prior year) was driven by this Chugai collaboration agreement.
2. Co-Development Partnerships (ProGen): 50/50 co-development partnership with ProGen Co., Ltd. for RT-114 (oral GLP-1/GLP-2 for obesity); partners provide development funding and commercial infrastructure, Rani provides the delivery platform and execution capabilities.
3. Technology Licensing & Milestone Payments: Partners provide upfront, milestone, and program-level funding that supports advancement across the RaniPill® portfolio under a complementary collaboration model.
4. Pre-Revenue Drug Product Sales: Company is clinical-stage and pre-commercial; no approved drug products on market. Future revenue expected from product sales and/or royalties once partnered or own programs reach commercialization.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Rani Therapeutics develops the RaniPill® platform — a swallowable, robotic, enteric-coated capsule with a self-inflating balloon and dissolvable microneedles that delivers biologic drugs orally through the intestinal wall with bioavailability comparable to subcutaneous injection (102% relative to SC in human testing). The company is clinical-stage and partners with large pharma to co-develop and license oral formulations of injectable biologics across obesity, immunology, endocrinology, and rare disease indications (e.g., Chugai at up to $1.085B, ProGen 50/50 co-development on RT-114, and Celltrion biosimilar supply for RT-111 and RT-105).

Product overview

Rani Therapeutics is a clinical-stage biotherapeutics company built around a single, unified proprietary platform — the RaniPill® robotic capsule — which it uses to develop a portfolio of oral biologic drug candidates. The RaniPill® core platform acts as the enabling oral delivery technology, while individual pipeline programs (RT-114, RT-116, RT-105, RT-111, and RT-117) are distinct drug candidates targeting obesity, immunology (psoriatic arthritis, psoriasis), and rare disease, several of which are advanced through strategic partnerships with ProGen Co., Ltd., Chugai Pharmaceutical, and Celltrion, Inc. Rani was established after several years as a research project within InCube Labs, Mir Imran's life sciences lab, and is headquartered in San Jose, California with an additional office in Fremont.

Differentiator

Problem solved

Functional benefit

Brands

• RaniPill®: Proprietary, simple-to-swallow robotic capsule platform that delivers biologic drugs orally through the intestinal wall, offering injectable-like bioavailability without a needle; the company's core technology platform.

Products and services

• RaniPill® Platform A simple-to-swallow, robotic, enteric-coated capsule platform with a self-inflating balloon and dissolvable microneedles that delivers biologic drugs orally through the intestinal wall, achieving 102% bioavailability relative to subcutaneous injection. Payload-agnostic across peptides, proteins, monoclonal antibodies, and nucleotides; 200μL liquid drug capacity. Licensed and co-developed with enterprise pharma partners.
• RT-114 (oral GLP-1/GLP-2 for obesity) Clinical-stage oral GLP-1/GLP-2 receptor agonist biologic candidate delivered via the RaniPill® platform for the treatment of obesity. Subject of a worldwide 50/50 co-development partnership with ProGen Co., Ltd.; advancing through a Phase 1 study via the RaniPill® platform.
• RT-116 (oral Semaglutide for obesity) Preclinical-stage oral semaglutide program delivered via the RaniPill® platform for obesity. Rani presented preclinical data at ObesityWeek® 2025 showing oral semaglutide via RaniPill® is bioequivalent to subcutaneous injection in dogs and leads to similar weight loss.
• RT-105 (Adalimumab Biosimilar for Psoriatic Arthritis) Preclinical-stage oral adalimumab biosimilar delivered via the RaniPill® platform for psoriatic arthritis. Adalimumab biosimilar is supplied by Celltrion, Inc. under a license and drug supply agreement.
• RT-111 (Ustekinumab Biosimilar for Psoriasis) Clinical-stage oral ustekinumab biosimilar delivered via the RaniPill® platform for psoriasis. Ustekinumab biosimilar is supplied by Celltrion, Inc. under a license and drug supply agreement.
• RT-117 (Rare Disease Oral Therapy) Discovery-stage oral rare disease therapy delivered via the RaniPill® platform. Subject of a worldwide collaboration and license agreement with Chugai Pharmaceutical Co., Ltd. valued at up to $1.085 billion covering 11 predefined targets, with upfront payment, success milestones, and royalties.

Quantifiable outcome

• 102% bioavailability relative to subcutaneous injection
• +5 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered core and flagship.

• ProGen Co., Ltd.coreStrategic or Co-development Partner · 23 October 2025Worldwide 50/50 co-development partnership for RT-114, an oral GLP-1/GLP-2 receptor agonist for obesity, advancing into a Phase 1 study via the RaniPill® platform. ProGen provides development funding and commercial infrastructure; Rani provides the delivery platform and end-to-end execution.
• Chugai Pharmaceutical Co., Ltd.flagshipStrategic or Co-development Partner · 17 October 2025Worldwide collaboration and license agreement to develop an oral therapy for a rare disease using the RaniPill® platform (RT-117 program). Total potential collaboration value of up to $1.085 billion, with upfront payment and success milestones. Agreement covers 11 predefined targets sharing the same financial terms as the original deal. Validates the RaniPill® platform as one of two major pharmaceutical partnerships.
• Celltrion, Inc.coreOEM/ Whitelabel/ Licensing Partner · 17 October 2025Supplies ustekinumab and adalimumab biosimilars and grants Rani a license and drug supply for each drug used with the RaniPill® capsule — supporting RT-111 (ustekinumab biosimilar for psoriasis) and RT-105 (adalimumab biosimilar for psoriatic arthritis) programs.

Scale indicators18 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Lyndra Therapeutics: Clinical-stage company developing oral, ultra-long-acting drug delivery systems, including the LYNX™ platform for oral biologics and peptides. Directly comparable to Rani's RaniPill® as a fellow oral-biologic delivery platform pursuing the same fundamental thesis of replacing injections with oral dosing.
• Oramed Pharmaceuticals: Clinical-stage company developing oral protein delivery technology (ORMD-0801 oral insulin), with a platform applicable to other biologics. Directly comparable to Rani in pioneering oral biologic delivery for chronic conditions, although targeting metabolic disease first.
• Enteris BioPharma: Specializes in oral peptide and small molecule formulation via its Peptelligence® and ProPerma™ oral delivery platforms, licensing to pharma partners. Directly comparable to Rani as a B2B oral-peptide delivery enabler serving large pharma.
• Biora Therapeutics: Developing targeted oral biotherapeutics via the PEE™ (Phago-based) and NaviCap™ platforms for GI-tissue drug delivery. Comparable to Rani as a clinical-stage oral biologic delivery company using a device-plus-biologic approach.

Broad incumbents

• Halozyme Therapeutics: Commercial-stage drug delivery company with the ENHANZE® platform (recombinant human hyaluronidase) that enables SC injection of large-volume biologics. Broader incumbent in biologic delivery enabling, with mature royalty revenue model analogous to Rani's long-term licensing vision.
• Novo Nordisk: Global biopharma leader with the only approved oral GLP-1 (Rybelsus/oral semaglutide) and the originator of injectable semaglutide (Ozempic/Wegovy). Competes directly with Rani's RT-116 (oral semaglutide via RaniPill®) and broader obesity pipeline.
• Eli Lilly: Owns the leading injectable GLP-1 franchise (Mounjaro/Zepbound) and is advancing oral GLP-1 candidates (e.g., orforglipron). A potential Rani partner for oral biologics expansion but also a major competitive threat in obesity.
• Catalent: Large-scale contract drug development and delivery organization offering oral, injectable, and biologic formulation services. Broader incumbent with extensive pharma partnerships in drug delivery, comparable to Rani's licensing and co-development motion at scale.
• West Pharmaceutical Services: Global manufacturer of drug delivery components including injectable elastomers, containment systems, and devices. Comparable to Rani as a device-side delivery platform company serving biologic pharma partners, though focused on injectable rather than oral delivery.
• AbbVie: Originator of Humira (adalimumab), the franchise most directly comparable to Rani's RT-105 adalimumab biosimilar program; also a leader in immunology biologics. A potential RaniPill® partner for lifecycle management of injectable biologics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors24 records

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M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Rani Therapeutics