Therapeutics · Gastrointestinal drug delivery
Intact Therapeutics
A Stanford spinout developing a gel that pours like a liquid and sets inside the colon at body temperature. Public grants have paid for the science. As of September 2026 no trial is registered under the company name and no peer-reviewed paper carries its address.
The patient who could not hold it in
A gastroenterologist at Stanford met a man who had taken oral steroids for distal ulcerative colitis for more than fifty years, for a disease confined to the last stretch of his colon. All of it could have been treated locally. The physician asked why he had never used a topical therapy.
The answer, as Sidhartha Sinha told Stanford’s Biodesign program: “I’ve tried it many times; I just can’t hold it in.”
That sentence is the company. An enema is a liquid, and a liquid in an inflamed rectum wants to come straight back out. A drug that cannot stay in place is not a drug.
The gap topical therapy cannot reach
Ulcerative colitis affects about one million people in the United States, according to the project summary of the company’s NIH grant. Most are treated systemically: corticosteroids for flares, then anti-TNF agents, anti-integrins, anti-IL-12/IL-23 drugs or small molecules. Those work through the whole body to fix inflammation in one part of it.
Topical therapy should be the obvious answer for disease limited to the rectum and left colon. It has a reach problem. Enemas travel furthest, as far as the splenic flexure, and are the hardest to keep in.
Intact’s idea is to have it both ways. A formulation that is liquid at room temperature travels like an enema. Warmed by the body a few degrees, polymers in the mix turn it into a viscous, mucoadhesive gel that clings to inflamed tissue instead of draining away.
A physician and a fellowship classmate
Sinha is a practicing gastroenterologist whose Stanford profile lists him as an assistant professor in gastroenterology and hepatology. He is the company’s founder and scientific advisor, not its operator. Ravi Pamnani, from the same Stanford Biodesign Innovation Fellowship class of 2010 to 2011, is CEO and co-founder.
Sinha has been candid about what he did not bring: he had the clinical insight and the Biodesign training, but had never developed a drug product and had no background in biomaterials or polymer chemistry. The company was built by adding people who did. Jeffrey Linhardt is the principal investigator on both the NIH award and the state grant. Lorin K. Johnson, a board member and scientific advisor, appears in the 2025 partnership announcement.
Intact incorporated in 2015 and went through Y Combinator in the Winter 2019 batch, which put a Stanford clinical spinout in a cohort better known for software.
Four grants, three targets
Intact has pulled a public grant roughly once a year for five years, and each points at a different problem. In 2020 the National Science Foundation funded a thermogel for upper gastrointestinal bleeding, the program the company calls INT-201. The Phase I award was $224,999. In 2022 the California Institute for Regenerative Medicine added $942,050 for a locally delivered RSpo1 formulation aimed at the mouth rather than the gut, for oral mucositis after chemotherapy or radiation. In 2023 the National Institutes of Health funded INT-102, a thermogel carrying a microbial metabolite derived agonist of the pregnane X receptor for moderate to severe distal colitis, at $296,475. In 2024 NSF came back with a Phase II award of $999,783 to carry the bleeding program to what the abstract calls the “clinical trial-ready stage.”
Add them and the public money on record comes to $2,463,307. Every startup database that tries to total Intact’s funding reports a smaller number.
The gastroparesis option that lapsed
On June 17, 2025, the Nasdaq-listed Processa Pharmaceuticals announced a binding term sheet giving Intact an exclusive option to license PCS12852, a selective 5-HT4 receptor agonist that had completed a Phase 2a trial in diabetic gastroparesis. The headline numbers were large: a $2.5 million option fee, up to $20 million in development and regulatory milestones, more than $432.5 million in commercial milestones, double-digit royalties, and a “3.5% equity stake in Intact Therapeutics” on closing. Processa shares rose more than 15 percent that session.
It never closed. On February 12, 2026, Processa reported that the term sheet “had expired without the parties executing a definitive license agreement.” Neither side has said publicly why.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| NSF SBIR Phase I | $224,999, award year 2020, for a thermogel platform for upper gastrointestinal bleeding. | Public record |
| NSF SBIR Phase II | $999,783, contract 2307164, award year 2024, solicitation NSF 22-552. Goal stated in the abstract: bring the thermogel product to the “clinical trial-ready stage.” | Public record |
| NIH SBIR Phase I | 1R43DK136359-01, NIDDK, $296,475, June 2023 to May 2025, PI Jeffrey Linhardt. Funds “a novel topical therapeutic product (INT-102) for the treatment of moderate-to-severe, distal UC.” The aims are formulation, pharmacokinetics in vivo and a murine colitis model, with GLP IND-enabling studies described as future Phase II work. | Public record |
| CIRM award | DISC2-13232, Quest Discovery Stage, $942,050, for RSpo1 to prevent and treat oral mucositis. Status listed as closed. | Public record |
| Patents | Four published applications name Intact Therapeutics, Inc.: dosing methods for inflammatory bowel conditions (May 2020 and May 2021), compositions for gastrointestinal bleeding (April 2021), mesalamine formulations (February 2023). | Public record |
| Human data | Described only in a Stanford Biodesign interview: animal studies, a preliminary healthy subject study comparing retention and reach against a standard liquid enema, and mesalamine testing in two colitis patients under IRB approval. No protocol, sample size or results published. | Interview |
| Registered trials | No study on ClinicalTrials.gov lists Intact as sponsor, and none was found for INT-102 or INT-201, as of Sep 23, 2026. The PCS12852 Phase 2a study, NCT05270460, was sponsored by Processa and completed in 2022. | Not found |
| Peer-reviewed papers | No PubMed record carries an Intact Therapeutics affiliation as of Sep 23, 2026. | Not found |
| FDA records | No approval, clearance or marketing record. The FDA entries returned for the name belong to Intact Medical Corporation and to the vascular company later absorbed by Philips. | Not found |
| “Clinical-stage” label | The website calls Intact a “clinical-stage biopharmaceutical company,” and a defense consortium profile repeats it. The registry shows no trial, and the NIH award funds preclinical aims with IND-enabling work ahead. GlobalData placed INT-102 in Phase I in January 2025. | Differs from the record |
| Processa option | Binding term sheet signed June 17, 2025; reported expired February 12, 2026, with no definitive agreement and no further obligations for either side. | Public record |
Read plainly: reviewers at three agencies found the mechanism worth funding, and the platform has real public validation. The clinical claim is ahead of the clinical record. What exists in the open literature is animal models, an unpublished healthy subject comparison, two treated patients described in an interview, and no registered study.
What to watch
- A first registered trial for INT-102 or INT-201. The NIH aims put GLP IND-enabling studies in the next phase, not this one.
- Publication of the healthy subject retention study, the one dataset that would show the gel does what the founding insight promises.
- What happens to PCS12852 now that the option has lapsed, and whether Intact pursues a motility asset another way.
- The close of the NSF Phase II award, and whether a commercialization partner follows it.
- Any equity financing, which would show up as a Form D within 15 days of a first sale. None has ever been filed under the company name.
In their words
“I’ve tried it many times; I just can’t hold it in.”
A patient with distal ulcerative colitis, recounted by Sidhartha Sinha · Interview
“The simple idea was to develop a formulation that would be liquid at room temperature, allowing it to travel far into the colon like a regular enema.”
Sidhartha Sinha, founder, Stanford Biodesign interview · Interview
“Every single patient found it easier to retain Intact’s formulation than a traditional enema, and we also validated that it gets as far into the colon as the liquid enema.”
Sidhartha Sinha, on the healthy subject study · Interview
“We have tested it in two human patients with ulcerative colitis so far, with good results in terms healing the colon and also being easier to use.”
Sidhartha Sinha, Biodesign interview · Interview
“Suppositories are only active in the rectum, and foams can only reach the sigmoid colon.”
Project summary, NIH award 1R43DK136359-01, 2023 · Public record
“Currently, there are no products on the market that can be utilized to quickly stop UGIB prior to endoscopic treatment.”
Abstract, NSF award 2307164, 2024 · Public record
“At Intact, we are building a company around the idea that there remain significant unmet clinical needs in GI”
Ravi Pamnani, CEO and co-founder, June 2025 release · Company release
Related companies
Sources
- Public recordSBIR.gov company portfolio, three awards totaling $1,521,257
- Public recordNSF SBIR Phase II award, contract 2307164, $999,783
- Public recordNIH RePORTER 1R43DK136359-01, NIDDK, $296,475
- Public recordCIRM grant award DISC2-13232, $942,050
- Public recordGoogle Patents query, four applications assigned to Intact
- Public recordClinicalTrials.gov queries, Intact Therapeutics and INT-102
- Public recordPubMed query for an Intact Therapeutics affiliation
- Public recordSEC EDGAR Form D filings mentioning the name Intact
- InterviewAn Interview with Sidhartha Sinha of Intact Therapeutics
- IndependentSidhartha Sinha faculty profile
- IndependentProcessa Ends PCS12852 Licensing Pact With Intact Therapeutics
- IndependentINT-102 by Intact Therapeutics for Ulcerative Colitis: Likelihood of Approval
- Independent$452M Deal: Processa’s Phase 2 Gastroparesis Drug Attracts Licensing Interest
- IndependentIntact Therapeutics company profile
- IndependentINT-201 for upper gastrointestinal bleeding
- CompanyProcessa signs binding term sheet granting Intact an option on PCS12852
- CompanyIntact Therapeutics website
- CompanyY Combinator company page, Winter 2019
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
